An Adaptive Behavioral Intervention for Weight Loss Management: A Randomized Clinical Trial.

Importance: Lifestyle interventions for weight loss are difficult to implement in clinical practice. Self-managed mobile health implementations without or with added support after unsuccessful weight loss attempts could offer effective population-level obesity management. Objective: To test whether a wireless feedback system (WFS) yields noninferior weight loss vs WFS plus telephone coaching and whether participants who do not respond to initial treatment achieve greater weight loss with more vs less vigorous step-up interventions. Design, Setting, and Participants: In this noninferiority randomized trial, 400 adults aged 18 to 60 years with a body mass index of 27 to 45 were randomized in a 1:1 ratio to undergo 3 months of treatment initially with WFS or WFS plus coaching at a US academic medical center between June 2017 and March 2021. Participants attaining suboptimal weight loss were rerandomized to undergo modest or vigorous step-up intervention. Interventions: The WFS included a Wi-Fi activity tracker and scale transmitting data to a smartphone app to provide daily feedback on progress in lifestyle change and weight loss, and WFS plus coaching added 12 weekly 10- to 15-minute supportive coaching calls delivered by bachelor's degree-level health promotionists viewing participants' self-monitoring data on a dashboard; step-up interventions included supportive messaging via mobile device screen notifications (app-based screen alerts) without or with coaching or powdered meal replacement. Participants and staff were unblinded and outcome assessors were blinded to treatment randomization. Main Outcomes and Measures: The primary outcome was the between-group difference in 6-month weight change, with the noninferiority margin defined as a difference in weight change of -2.5 kg; secondary outcomes included between-group differences for all participants in weight change at 3 and 12 months and between-group 6-month weight change difference among nonresponders exposed to modest vs vigorous step-up interventions. Results: Among 400 participants (mean [SD] age, 40.5 [11.2] years; 305 [76.3%] women; 81 participants were Black and 266 were White; mean [SD] body mass index, 34.4 [4.3]) randomized to undergo WFS (n = 199) vs WFS plus coaching (n = 201), outcome data were available for 342 participants (85.5%) at 6 months. Six-month weight loss was -2.8 kg (95% CI, -3.5 to -2.0) for the WFS group and -4.8 kg (95% CI, -5.5 to -4.1) for participants in the WFS plus coaching group (difference in weight change, -2.0 kg [90% CI, -2.9 to -1.1]; P < .001); the 90% CI included the noninferiority margin of -2.5 kg. Weight change differences were comparable at 3 and 12 months and, among nonresponders, at 6 months, with no difference by step-up therapy. Conclusions and Relevance: A wireless feedback system (Wi-Fi activity tracker and scale with smartphone app to provide daily feedback) was not noninferior to the same system with added coaching. Continued efforts are needed to identify strategies for weight loss management and to accurately select interventions for different individuals to achieve weight loss goals. Trial Registration: ClinicalTrials.gov Identifier: NCT02997943.

Digitally characterizing the dynamics of multiple health behavior change.

OBJECTIVE: We applied the ORBIT model to digitally define dynamic treatment pathways whereby intervention improves multiple risk behaviors. We hypothesized that effective intervention improves the frequency and consistency of targeted health behaviors and that both correlate with automaticity (habit) and self-efficacy (self-regulation). METHOD: Study 1: Via location scale mixed modeling we compared effects when hybrid mobile intervention did versus did not target each behavior in the Make Better Choices 1 (MBC1) trial (n = 204). Participants had all of four risk behaviors: low moderate-vigorous physical activity (MVPA) and fruit and vegetable consumption (FV), and high saturated fat (FAT) and sedentary leisure screen time (SED). Models estimated the mean (location), between-subjects variance, and within-subject variance (scale). RESULTS: Treatment by time interactions showed that location increased for MVPA and FV (Bs = 1.68, .61; ps < .001) and decreased for SED and FAT (Bs = -2.01, -.07; ps < .05) more when treatments targeted the behavior. Within-subject variance modeling revealed group by time interactions for scale (taus = -.19, -.75, -.17, -.11; ps < .001), indicating that all behaviors grew more consistent when targeted. METHOD: Study 2: In the MBC2 trial (n = 212) we examined correlations between location, scale, self-efficacy, and automaticity for the three targeted behaviors. RESULTS: For SED, higher scale (less consistency) but not location correlated with lower self-efficacy (r = -.22, p = .014) and automaticity (r = -.23, p = .013). For FV and MVPA, higher location, but not scale, correlated with higher self-efficacy (rs = .38, .34, ps < .001) and greater automaticity (rs = .46, .42, ps < .001). CONCLUSIONS: Location scale mixed modeling suggests that both habit and self-regulation changes probably accompany acquisition of complex diet and activity behaviors. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

A Factorial Experiment to Optimize Remotely Delivered Behavioral Treatment for Obesity: Results of the Opt-IN Study.

OBJECTIVE: Intensive behavioral obesity treatments face scalability challenges, but evidence is lacking about which treatment components could be cut back without reducing weight loss. The Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity (Opt-IN) study applied the Multiphase Optimization Strategy to develop an entirely remotely delivered, technology-supported weight-loss package to maximize the amount of weight loss attainable for ≤$500. METHODS: Six-month weight loss was examined among adults (N = 562) with BMI ≥ 25 who were randomly assigned to conditions in a factorial experiment crossing five dichotomous treatment components set to either low/high (12 vs. 24 coaching calls) or off/on (primary care provider reports, text messaging, meal replacements, and buddy training). RESULTS: About 84.3% of participants completed the final assessment. The treatment package yielding maximum weight loss for ≤$500 included 12 coaching calls, buddy training, and primary care provider progress reports; produced average weight loss of 6.1 kg, with 57.1% losing ≥5% and 51.8% losing ≥7%; and cost $427 per person. The most expensive candidate-treatment component (24 vs. 12 coaching calls) was screened out of the optimized treatment package because it did not increase weight loss. CONCLUSIONS: Systematically testing each treatment component's effect on weight loss made it possible to eliminate more expensive but less impactful components, yielding an optimized, resource-efficient obesity treatment for evaluation in a randomized controlled trial.

Online, cross-disciplinary team science training for health and medical professionals: Evaluation of COALESCE (teamscience.net).

INTRODUCTION: The National Academies of Sciences (NAS) emphasize the need for interdisciplinary team science (TS) training, but few training resources are available. COALESCE, an open-access tool developed with National Institutes of Health support and located at teamscience.net, is considered a gold standard resource but has not previously been evaluated. COALESCE launched four learning modules in 2011. The Science of TS (SciTS) module, an interactive encyclopedia, introduces foundational concepts. Three scenario-based modules simulate TS challenges in behavioral, clinical, and basic biomedical sciences. This study examined user characteristics, usage patterns, and effects of completing the four modules on TS knowledge, attitudes, and skills. METHODS: Repeated measures ANOVA tested for pre-post changes in performance and compared learning by users with biomedical versus other disciplinary backgrounds. RESULTS: From 2011 through 2017, the site attracted 16,280 new users who engaged in 6461 sessions that lasted more than 1 min. The modal registrant identified as working in a biomedical field (47%), in an academic institution (72%), and expressed greater interest in the practice than the SciTS (67%). Those completing pre- and post-tests (n = 989) showed significant improvement in knowledge, attitudes, and skills after taking all scenario-based modules (p < 0.005); knowledge and attitudes were unchanged after the SciTS encyclopedia. Biomedical and other health professionals improved comparably. CONCLUSION: Evaluation of the TS training tool at teamscience.net indicates broad dissemination and positive TS-related outcomes. Site upgrades implemented between 2018 and 2020, including adding five new modules, are expected to increase the robustness and accessibility of the COALESCE training resource.

SMART: Study protocol for a sequential multiple assignment randomized controlled trial to optimize weight loss management.

BACKGROUND: Stepped care is a rational resource allocation approach to reduce population obesity. Evidence is lacking to guide decisions on use of low cost treatment components such as mobile health (mHealth) tools without compromising weight loss of those needing more expensive traditional treatment components (e.g., coaching, meal replacement). A sequential multiple assignment randomization trial (SMART) will be conducted to inform the development of an empirically based stepped care intervention that incorporates mHealth and traditional treatment components. OBJECTIVE: The primary aim tests the non-inferiority of app alone, compared to app plus coaching, as first line obesity treatment, measured by weight change from baseline to 6 months. Secondary aims are to identify the best tactic to address early treatment non-response and the optimal treatment sequence for resource efficient weight loss. STUDY DESIGN: Four hundred participants, 18-60 years old with Body Mass Index between 27 and 45 kg/m2 will be randomized to receive a weight loss smartphone app (APP) or the app plus weekly coaching (APP + C) for a 12 week period. Those achieving <0.5 lb. weight loss on average per week, assessed by wireless scale at 2, 4, and 8 weeks, will be classified as non-responders and re-randomized once to step-up modestly (adding another mHealth component) or vigorously (adding mHealth and traditional treatment components) for the remaining treatment period. Weight will be assessed in person at baseline, 3, 6, and 12 months. SIGNIFICANCE: Results will inform construction of an obesity treatment algorithm that balances weight loss outcomes with resource consumption.

Multicomponent mHealth Intervention for Large, Sustained Change in Multiple Diet and Activity Risk Behaviors: The Make Better Choices 2 Randomized Controlled Trial.

BACKGROUND: Prevalent co-occurring poor diet and physical inactivity convey chronic disease risk to the population. Large magnitude behavior change can improve behaviors to recommended levels, but multiple behavior change interventions produce small, poorly maintained effects. OBJECTIVE: The Make Better Choices 2 trial tested whether a multicomponent intervention integrating mHealth, modest incentives, and remote coaching could sustainably improve diet and activity. METHODS: Between 2012 and 2014, the 9-month randomized controlled trial enrolled 212 Chicago area adults with low fruit and vegetable and high saturated fat intakes, low moderate to vigorous physical activity (MVPA) and high sedentary leisure screen time. Participants were recruited by advertisements to an open-access website, screened, and randomly assigned to either of two active interventions targeting MVPA simultaneously with, or sequentially after other diet and activity targets (N=84 per intervention) or a stress and sleep contact control intervention (N=44). They used a smartphone app and accelerometer to track targeted behaviors and received personalized remote coaching from trained paraprofessionals. Perfect behavioral adherence was rewarded with an incentive of US $5 per week for 12 weeks. Diet and activity behaviors were measured at baseline, 3, 6, and 9 months; primary outcome was 9-month diet and activity composite improvement. RESULTS: Both simultaneous and sequential interventions produced large, sustained improvements exceeding control (P<.001), and brought all diet and activity behaviors to guideline levels. At 9 months, the interventions increased fruits and vegetables by 6.5 servings per day (95% CI 6.1-6.8), increased MVPA by 24.7 minutes per day (95% CI 20.0-29.5), decreased sedentary leisure by 170.5 minutes per day (95% CI -183.5 to -157.5), and decreased saturated fat intake by 3.6% (95% CI -4.1 to -3.1). Retention through 9-month follow-up was 82.1%. Self-monitoring decreased from 96.3% of days at baseline to 72.3% at 3 months, 63.5% at 6 months, and 54.6% at 9 months (P<.001). Neither attrition nor decline in self-monitoring differed across intervention groups. CONCLUSIONS: Multicomponent mHealth diet and activity intervention involving connected coaching and modest initial performance incentives holds potential to reduce chronic disease risk. TRIAL REGISTRATION: ClinicalTrials.gov NCT01249989; https://clinicaltrials.gov/ct2/show/NCT01249989 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT01249989).

Daily and Seasonal Influences on Dietary Self-monitoring Using a Smartphone Application.

OBJECTIVE: To examine within-person variation in dietary self-monitoring during a 6-month technology-supported weight loss trial as a function of time-varying factors including time in the study, day of the week, and month of the year. METHODS: Smartphone self-monitoring data were examined from 31 obese adults (aged 18-60 years) who participated in a 6-month technology-supported weight loss program. Multilevel regression modeling was used to examine within-person variation in dietary self-monitoring. RESULTS: Participants recorded less as time in the study progressed. Fewer foods were reported on the weekends compared with weekdays. More foods were self-monitored in January compared with October; however, a seasonal effect was not observed. CONCLUSIONS AND IMPLICATIONS: The amount of time in a study and day of the week were associated with dietary self-monitoring but not season. Future studies should examine factors that influence variations in self-monitoring and identify methods to improve technology-supported dietary self-monitoring adherence.

Effects of an abbreviated obesity intervention supported by mobile technology: The ENGAGED randomized clinical trial.

OBJECTIVE: To determine the effects on weight loss of three abbreviated behavioral weight loss interventions with and without coaching and mobile technology. METHODS: A randomized controlled efficacy study of three 6-month weight loss treatments was conducted in 96 adults with obesity: 1) self-guided (SELF), 2) standard (STND), or 3) technology-supported (TECH). STND and TECH received eight in-person group treatment sessions. SELF and STND used paper diaries to self-monitor diet, activity, and weight; TECH used a smartphone application with social networking features and wireless accelerometer. RESULTS: Weight loss was greater for TECH and STND than SELF at 6 months (-5.7 kg [95% confidence interval: -7.2 to -4.1] vs. -2.7 kg [95% confidence interval: -5.1 to -0.3], P < 0.05) but not 12 months. TECH and STND did not differ except that more STND (59%) than TECH (34%) achieved ≥ 5% weight loss at 6 months (P < 0.05). Self-monitoring adherence was greater in TECH than STND (P < 0.001), greater in both interventions than SELF (P < 0.001), and covaried with weight loss (r(84) = 0.36-0.51, P < 0.001). CONCLUSIONS: Abbreviated behavioral counseling can produce clinically meaningful weight loss regardless of whether self-monitoring is performed on paper or smartphone, but long-term superiority over standard of care self-guided treatment is challenging to maintain.

Lifestyle intervention effects on the frequency and duration of daily moderate-vigorous physical activity and leisure screen time.

OBJECTIVE: How a healthy lifestyle intervention changes the frequency and duration of daily moderate-vigorous physical activity and sedentary behavior has not been well characterized. Secondary analyses of data from the Make Better Choices randomized controlled trial were conducted to evaluate how interventions to increase physical activity or reduce leisure screen time affected the frequency and duration of these behaviors during treatment initiation and follow-up. METHOD: Participants were 202 adults who exhibited insufficient physical activity, excessive screen time and poor diet during a 14-day baseline screening period. The design was a randomized controlled trial with a 3-week intervention period followed by eight 3- to 7-day bursts of data collection over the 6-month follow-up period after intervention termination. Participants self-reported on their physical activity and screen time at the end of each day. RESULTS: A 2-part multilevel model indicated that, relative to baseline levels, the physical activity intervention increased the odds of daily moderate-vigorous intensity physical activity (frequency) but not the duration of activity during the intervention period and these effects persisted (albeit somewhat more weakly) during the follow-up period. The screen time intervention reduced both the frequency and duration of daily screen time from the beginning of the intervention through the follow-up period. CONCLUSIONS: A 3-week intervention increased daily physical activity frequency but not duration, and reduced both the frequency and duration of daily leisure screen time. These effects were maintained over 20 weeks following the end of the intervention. (PsycINFO Database Record

Mechanisms of Change in Diet and Activity in the Make Better Choices 1 Trial.

OBJECTIVE: The Make Better Choices 1 trial demonstrated that participants with unhealthy diet and activity behaviors who were randomized to increase fruits/vegetables and decrease sedentary leisure achieved greater diet and activity improvement than those randomized to change other pairs of eating and activity behaviors. Participants randomized to decrease saturated fat and increase physical activity achieved the least diet-activity improvement. This study examined which psychological mechanisms mediated the effects of the study treatments on healthy behavior change. METHODS: Participants (n = 204) were randomized to 1 of 4 treatments: increase fruits/vegetables and physical activity; decrease saturated fat and sedentary leisure; decrease saturated fat and increase physical activity; increase fruits/vegetables and decrease sedentary leisure. Treatments provided 3 weeks of remote coaching supported by mobile decision support technology and financial incentives. Mediational analyses were performed to examine whether changes in positive and negative affect, and self-efficacy, stages of readiness to change, liking, craving and attentional bias for fruit/vegetable intake, saturated fat intake, physical activity, and sedentary leisure explained the impact of the treatments on diet-activity improvement. RESULTS: Greater diet-activity improvement in those randomized to increase fruits/vegetables and decrease sedentary leisure was mediated by increased self-efficacy (indirect effect estimate = 0.04; 95% bias corrected CI, 0.003-0.11). All treatments improved craving, stage of change and positive affect. CONCLUSION: Accomplishing healthy lifestyle changes for 3 weeks improves positive affect, increases cravings for healthy foods and activities, and enhances readiness to make healthy behavior changes. Maximal diet and activity improvement occurs when interventions enhance self-efficacy to make multiple healthy behavior changes. (PsycINFO Database Record

Design and protocol of a randomized multiple behavior change trial: Make Better Choices 2 (MBC2).

BACKGROUND: Suboptimal diet and inactive lifestyle are among the most prevalent preventable causes of premature death. Interventions that target multiple behaviors are potentially efficient; however the optimal way to initiate and maintain multiple health behavior changes is unknown. OBJECTIVE: The Make Better Choices 2 (MBC2) trial aims to examine whether sustained healthful diet and activity change are best achieved by targeting diet and activity behaviors simultaneously or sequentially. Study design approximately 250 inactive adults with poor quality diet will be randomized to 3 conditions examining the best way to prescribe healthy diet and activity change. The 3 intervention conditions prescribe: 1) an increase in fruit and vegetable consumption (F/V+), decrease in sedentary leisure screen time (Sed-), and increase in physical activity (PA+) simultaneously (Simultaneous); 2) F/V+ and Sed- first, and then sequentially add PA+ (Sequential); or 3) Stress Management Control that addresses stress, relaxation, and sleep. All participants will receive a smartphone application to self-monitor behaviors and regular coaching calls to help facilitate behavior change during the 9 month intervention. Healthy lifestyle change in fruit/vegetable and saturated fat intakes, sedentary leisure screen time, and physical activity will be assessed at 3, 6, and 9 months. SIGNIFICANCE: MBC2 is a randomized m-Health intervention examining methods to maximize initiation and maintenance of multiple healthful behavior changes. Results from this trial will provide insight about an optimal technology supported approach to promote improvement in diet and physical activity.

Financial motivation undermines potential enjoyment in an intensive diet and activity intervention.

The use of material incentives in healthy lifestyle interventions is becoming widespread. However, self-determination theory (SDT) posits that when material incentives are perceived as controlling, they undermine intrinsic motivation. We analyzed data from the Make Better Choices trial-a trial testing strategies for improving four risk behaviors: low fruit-vegetable intake, high saturated fat intake, low physical activity, and high sedentary activity. At baseline, participants reported the degree to which financial incentives were an important motivator (financial motivation); self-reported enjoyment of each behavior was assessed before and after the 3-week incentivization phase. Consistent with SDT, after controlling for general motivation and group assignment, lower financial motivation predicted more adaptive changes in enjoyment. Whereas participants low in financial motivation experienced adaptive changes, adaptive changes were suppressed among those high in financial motivation.

Integrating technology into standard weight loss treatment: a randomized controlled trial.

BACKGROUND: A challenge in intensive obesity treatment is making care scalable. Little is known about whether the outcome of physician-directed weight loss treatment can be improved by adding mobile technology. METHODS: We conducted a 2-arm, 12-month study (October 1, 2007, through September 31, 2010). Seventy adults (body mass index >25 and ≤40 [calculated as weight in kilograms divided by height in meters squared]) were randomly assigned either to standard-of-care group treatment alone (standard group) or to the standard and connective mobile technology system (+mobile group). Participants attended biweekly weight loss groups held by the Veterans Affairs outpatient clinic. The +mobile group was provided personal digital assistants to self-monitor diet and physical activity; they also received biweekly coaching calls for 6 months. Weight was measured at baseline and at 3-, 6-, 9-, and 12-month follow-up. RESULTS: Sixty-nine adults received intervention (mean age, 57.7 years; 85.5% were men). A longitudinal intent-to-treat analysis indicated that the +mobile group lost a mean of 3.9 kg more (representing 3.1% more weight loss relative to the control group; 95% CI, 2.2-5.5 kg) than the standard group at each postbaseline time point. Compared with the standard group, the +mobile group had significantly greater odds of having lost 5% or more of their baseline weight at each postbaseline time point (odds ratio, 6.5; 95% CI, 2.5-18.6). CONCLUSIONS: The addition of a personal digital assistant and telephone coaching can enhance short-term weight loss in combination with an existing system of care. Mobile connective technology holds promise as a scalable mechanism for augmenting the effect of physician-directed weight loss treatment. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00371462.

Multiple behavior changes in diet and activity: a randomized controlled trial using mobile technology.

BACKGROUND: Many patients exhibit multiple chronic disease risk behaviors. Research provides little information about advice that can maximize simultaneous health behavior changes. METHODS: To test which combination of diet and activity advice maximizes healthy change, we randomized 204 adults with elevated saturated fat and low fruit and vegetable intake, high sedentary leisure time, and low physical activity to 1 of 4 treatments: increase fruit/vegetable intake and physical activity, decrease fat and sedentary leisure, decrease fat and increase physical activity, and increase fruit/vegetable intake and decrease sedentary leisure. Treatments provided 3 weeks of remote coaching supported by mobile decision support technology and financial incentives. During treatment, incentives were contingent on using the mobile device to self-monitor and attain behavioral targets; during follow-up, incentives were contingent only on recording. The outcome was standardized, composite improvement on the 4 diet and activity behaviors at the end of treatment and at 5-month follow-up. RESULTS: Of the 204 individuals randomized, 200 (98.0%) completed follow-up. The increase fruits/vegetables and decrease sedentary leisure treatments improved more than the other 3 treatments (P < .001). Specifically, daily fruit/vegetable intake increased from 1.2 servings to 5.5 servings, sedentary leisure decreased from 219.2 minutes to 89.3 minutes, and saturated fat decreased from 12.0% to 9.5% of calories consumed. Differences between treatment groups were maintained through follow-up. Traditional dieting (decrease fat and increase physical activity) improved less than the other 3 treatments (P < .001). CONCLUSIONS: Remote coaching supported by mobile technology and financial incentives holds promise to improve diet and activity. Targeting fruits/vegetables and sedentary leisure together maximizes overall adoption and maintenance of multiple healthy behavior changes.

Financial motivation undermines maintenance in an intensive diet and activity intervention.

Financial incentives are widely used in health behavior interventions. However, self-determination theory posits that emphasizing financial incentives can have negative consequences if experienced as controlling. Feeling controlled into performing a behavior tends to reduce enjoyment and undermine maintenance after financial contingencies are removed (the undermining effect). We assessed participants' context-specific financial motivation to participate in the Make Better Choices trial-a trial testing four different strategies for improving four health risk behaviors: low fruit and vegetable intake, high saturated fat intake, low physical activity, and high sedentary screen time. The primary outcome was overall healthy lifestyle change; weight loss was a secondary outcome. Financial incentives were contingent upon meeting behavior goals for 3 weeks and became contingent upon merely providing data during the 4.5-month maintenance period. Financial motivation for participation was assessed at baseline using a 7-item scale (α = .97). Across conditions, a main effect of financial motivation predicted a steeper rate of weight regained during the maintenance period, t(165) = 2.15, P = .04. Furthermore, financial motivation and gender interacted significantly in predicting maintenance of healthy diet and activity changes, t(160) = 2.42, P = .016, such that financial motivation had a more deleterious influence among men. Implications for practice and future research on incentivized lifestyle and weight interventions are discussed.

PDA+: A Personal Digital Assistant for Obesity Treatment - an RCT testing the use of technology to enhance weight loss treatment for veterans.

BACKGROUND: Obese adults struggle to make the changes necessary to achieve even modest weight loss, though a decrease in weight by as little as 10% can have significant health benefits. Failure to meet weight loss goals may in part be associated with barriers to obesity treatment. Wide-spread dissemination of evidence-based obesity treatment faces multiple challenges including cost, access, and implementing the programmatic characteristics on a large scale. AIMS: The PDA+: A Personal Digital Assistant for Obesity Treatment randomized controlled trial (RCT) was designed to test whether a PDA-based behavioral intervention enhances the effectiveness of the existing group weight loss treatment program at VA Medical Centers Managing Overweight/Obese Veterans Everywhere (MOVE!). We also aim to introduce technology as a way to overcome systemic barriers of traditional obesity treatment. METHODS/DESIGN: Veterans enrolled in the MOVE! group at the Hines Hospital VAMC with BMI ≥ 25 and ≤ 40 and weigh < 400 pounds, experience chronic pain (≥ 4 on the NRS-I scale for ≥ 6 months prior to enrollment) and are able to participate in a moderate intensity exercise program will be recruited and screened for eligibility. Participants will be randomized to receive either: a) MOVE! treatment alone (Standard Care) or b) Standard Care plus PDA (PDA+). Those randomized to PDA+ will record dietary intake, physical activity, and weight on the PDA. In addition, they will also record mood and pain intensity, and receive biweekly telephone support for the first 6-months of the 12-month study. All participants will attend in-person lab sessions every three months to complete questionnaires and for the collection of anthropomorphic data. Weight loss and decrease in pain level intensity are the primary outcomes. DISCUSSION: The PDA+ trial represents an important step in understanding ways to improve the use of technology in obesity treatment. The trial will address barriers to obesity care by implementing effective behavioral components of a weight loss intervention and delivering high intensity, low cost obesity treatment. This RCT also tests an intervention approach supported by handheld technology in a population traditionally considered to have lower levels of technology literacy. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00371462.

Make Better Choices (MBC): study design of a randomized controlled trial testing optimal technology-supported change in multiple diet and physical activity risk behaviors.

BACKGROUND: Suboptimal diet and physical inactivity are prevalent, co-occurring chronic disease risk factors, yet little is known about how to maximize multiple risk behavior change. Make Better Choices, a randomized controlled trial, tests competing hypotheses about the optimal way to promote healthy change in four bundled risk behaviors: high saturated fat intake, low fruit and vegetable intake, low physical activity, and high sedentary leisure screen time. The study aim is to determine which combination of two behavior change goals--one dietary, one activity--yields greatest overall healthy lifestyle change. METHODS/DESIGN: Adults (n = 200) with poor quality diet and sedentary lifestyle will be recruited and screened for study eligibility. Participants will be trained to record their diet and activities onto a personal data assistant, and use it to complete two weeks of baseline. Those who continue to show all four risk behaviors after baseline recording will be randomized to one of four behavior change prescriptions: 1) increase fruits and vegetables and increase physical activity, 2) decrease saturated fat and increase physical activity, 3) increase fruits and vegetable and decrease saturated fat, or 4) decrease saturated fat and decrease sedentary activity. They will use decision support feedback on the personal digital assistant and receive counseling from a coach to alter their diet and activity during a 3-week prescription period when payment is contingent upon meeting behavior change goals. They will continue recording on an intermittent schedule during a 4.5-month maintenance period when payment is not contingent upon goal attainment. The primary outcome is overall healthy lifestyle change, aggregated across all four risk behaviors. DISCUSSION: The Make Better Choices trial tests a disseminable lifestyle intervention supported by handheld technology. Findings will fill a gap in knowledge about optimal goal prescription to facilitate simultaneous diet and activity change. Results will shed light on which goal prescription maximizes healthful lifestyle change. TRIAL REGISTRATION: Clinical Trials Gov. Identifier NCT00113672.

ACCISS study rationale and design: activating collaborative cancer information service support for cervical cancer screening.

BACKGROUND: High-quality cancer information resources are available but underutilized by the public. Despite greater awareness of the National Cancer Institute's Cancer Information Service among low-income African Americans and Hispanics compared with Caucasians, actual Cancer Information Service usage is lower than expected, paralleling excess cancer-related morbidity and mortality for these subgroups. The proposed research examines how to connect the Cancer Information Service to low-income African-American and Hispanic women and their health care providers. The study will examine whether targeted physician mailing to women scheduled for colposcopy to follow up an abnormal Pap test can increase calls to the Cancer Information Service, enhance appropriate medical follow-up, and improve satisfaction with provider-patient communication. METHODS/DESIGN: The study will be conducted in two clinics in ethnically diverse low-income communities in Chicago. During the formative phase, patients and providers will provide input regarding materials planned for use in the experimental phase of the study. The experimental phase will use a two-group prospective randomized controlled trial design. African American and Hispanic women with an abnormal Pap test will be randomized to Usual Care (routine colposcopy reminder letter) or Intervention (reminder plus provider recommendation to call the Cancer Information Service and sample questions to ask). Primary outcomes will be: 1) calls to the Cancer Information Service; 2) timely medical follow-up, operationalized by whether the patient keeps her colposcopy appointment within six months of the abnormal Pap; and 3) patient satisfaction with provider-patient communication at follow-up. DISCUSSION: The study examines the effectiveness of a feasible, sustainable, and culturally sensitive strategy to increase awareness and use of the Cancer Information Service among an underserved population. The goal of linking a public service (the Cancer Information Service) with real-life settings of practice (the clinics), and considering input from patients, providers, and Cancer Information Service staff, is to ensure that the intervention, if proven effective, can be incorporated into existing care systems and sustained. The approach to study design and planning is aimed at bridging the gap between research and practice/service. TRIAL REGISTRATION: NCT00873288.

Behavioral intervention to promote smoking cessation and prevent weight gain: a systematic review and meta-analysis.

AIMS: The prospect of weight gain discourages many cigarette smokers from quitting. Practice guidelines offer varied advice about managing weight gain after quitting smoking, but no systematic review and meta-analysis have been available. We reviewed evidence to determine whether behavioral weight control intervention compromises smoking cessation attempts, and if it offers an effective way to reduce post-cessation weight gain. METHODS: We identified randomized controlled trials (RCTs) that compared combined smoking treatment and behavioral weight control to smoking treatment alone for adult smokers. English-language studies were identified through searches of PubMed, Ovid MEDLINE, CINAHL, EMBASE, PsycINFO and Cochrane Central Register of Controlled Trials. Of 779 articles identified and 35 potentially relevant RCTs screened, 10 met the criteria and were included in the meta-analysis. RESULTS: Patients who received both smoking treatment and weight treatment showed increased abstinence [odds ratio (OR) = 1.29, 95% confidence interval (CI) = 1.01, 1.64] and reduced weight gain (g = -0.30, 95% CI = -0.57, -0.02) in the short term (<3 months) compared with patients who received smoking treatment alone. Differences in abstinence (OR = 1.23, 95% CI = 0.85, 1.79) and weight control (g = -0.17, 95% CI = -0.42, 0.07) were no longer significant in the long term (>6 months). CONCLUSIONS: Findings provide no evidence that combining smoking treatment and behavioral weight control produces any harm and significant evidence of short-term benefit for both abstinence and weight control. However, the absence of long-term enhancement of either smoking cessation or weight control by the time-limited interventions studied to date provides insufficient basis to recommend societal expenditures on weight gain prevention treatment for patients who are quitting smoking.