Examining sociodemographic and health-related characteristics as moderators of an mHealth intervention on physical activity outcomes in young adult cancer survivors.

PURPOSE: This study explored whether sociodemographic and health-related characteristics moderated mHealth PA intervention effects on total and moderate-to-vigorous physical activity (MVPA) at 6 months, relative to a self-help condition among young adult cancer survivors (YACS). METHODS: We conducted exploratory secondary analyses of data from a randomized controlled trial among 280 YACS. All participants received digital tools; intervention participants also received lessons, adaptive goals, tailored feedback, text messages, and Facebook prompts. Potential moderators were assessed in baseline questionnaires. PA was measured at baseline and 6 months with accelerometers. Linear model repeated measures analyses examined within- and between-group PA changes stratified by levels of potential moderator variables. RESULTS: Over 6 months, the intervention produced MVPA increases that were ≥ 30 min/week compared with the self-help among participants who were males (28.1 vs. -7.7, p = .0243), identified with racial/ethnic minority groups (35.2 vs. -8.0, p = .0006), had baseline BMI of 25-30 (25.4 vs. -7.2, p = .0034), or stage III/IV cancer diagnosis (26.0 vs. -6.8, p = .0041). Intervention participants who were ages 26-35, college graduates, married/living with a partner, had a solid tumor, or no baseline comorbidities had modest MVPA increases over 6 months compared to the self-help (ps = .0163-.0492). Baseline characteristics did not moderate intervention effects on total PA. CONCLUSIONS: The mHealth intervention was more effective than a self-help group at improving MVPA among subgroups of YACS defined by characteristics (sex, race, BMI, cancer stage) that may be useful for tailoring PA interventions. IMPLICATIONS FOR CANCER SURVIVORS: These potential moderators can guide future optimization of PA interventions for YACS. GOV IDENTIFIER: NCT03569605.

Physical activity maintenance among young adult cancer survivors in an mHealth intervention: Twelve-month outcomes from the IMPACT randomized controlled trial.

BACKGROUND: Most physical activity (PA) interventions in young adult cancer survivors (YACS) have focused on short-term outcomes without evaluating longer-term outcomes and PA maintenance. This study examined the effects of an mHealth PA intervention at 12 months, after 6 months of tapered contacts, relative to a self-help group among 280 YACS. METHODS: YACS participated in a 12-month randomized trial that compared self-help and intervention groups. All participants received an activity tracker, smart scale, individual videochat session, and access to a condition-specific Facebook group. Intervention participants also received lessons, tailored feedback, adaptive goal setting, text messages, and Facebook prompts for 6 months, followed by tapered contacts. Accelerometer-measured and self-reported PA (total [primary outcome], moderate-to-vigorous [MVPA], light, steps, sedentary behaviors) were collected at baseline, 6, and 12 months. Generalized estimating equation analyses evaluated group effects on outcomes from baseline to 12 months. RESULTS: From baseline to 12 months, there were no between- or within-group differences in accelerometer-measured total PA min/week, while increases in self-reported total PA were greater in the intervention versus self-help group (mean difference = +55.8 min/week [95% CI, 6.0-105.6], p = 0.028). Over 12 months, both groups increased accelerometer-measured MVPA (intervention: +22.5 min/week [95% CI, 8.8-36.2] vs. self-help: +13.9 min/week [95% CI, 3.0-24.9]; p = 0.34), with no between-group differences. Both groups maintained accelerometer-measured and self-reported PA (total, MVPA) from 6 to 12 months. At 12 months, more intervention participants reported meeting national PA guidelines than self-help participants (47.9% vs. 33.1%, RR = 1.45, p = 0.02). CONCLUSION: The intervention was not more effective than the self-help group at increasing accelerometer-measured total PA over 12 months. Both groups maintained PA from 6 to 12 months. Digital approaches have potential for promoting sustained PA participation in YACS, but additional research is needed to identify what strategies work for whom, and under what conditions.

Effect of an mHealth intervention on physical activity outcomes among young adult cancer survivors: The IMPACT randomized controlled trial.

BACKGROUND: Physical inactivity is common in young adult cancer survivors (YACS), but evidence regarding effects of physical activity (PA) interventions among YACS is limited. The IMproving Physical Activity after Cancer Treatment (IMPACT) trial evaluated a theory-based mobile PA intervention on total PA minutes/week (primary) and secondary outcomes (moderate-to-vigorous PA [MVPA], light PA, steps, sedentary behaviors) at 6 months in YACS. METHODS: YACS (N = 280) were randomized to an intervention group or self-help group. All participants received digital tools (activity tracker, smart scale, access to arm-specific Facebook group) and an individual video chat session. Intervention participants also received a 6-month program with behavioral lessons, adaptive goal-setting, tailored feedback, tailored text messages, and Facebook prompts. PA was assessed via accelerometry and questionnaires at baseline and 6 months. Generalized estimating equation analyses tested between-group differences in changes over time. RESULTS: Of 280 YACS, 251 (90%) completed the 6-month accelerometry measures. Accelerometer-measured total PA minutes/week changed from 1974.26 at baseline to 2024.34 at 6 months in the intervention (mean change, 55.14 [95% CI, -40.91 to 151.19]) and from 1814.93 to 1877.68 in the self-help group (40.94 [95% CI, -62.14 to 144.02]; between-group p = .84). Increases in MVPA were +24.67 minutes/week (95% CI, 14.77-34.57) in the intervention versus +11.41 minutes/week in the self-help (95% CI, 1.44-21.38; between-group p = .07). CONCLUSION: Although the intervention did not result in significant differences in total PA, the increase in MVPA relative to the self-help group might be associated with important health benefits. Future research should examine moderators to identify for whom, and under what conditions, the intervention might be effective. CLINICALTRIALS: gov Identifier: NCT03569605. PLAIN LANGUAGE SUMMARY: Physical inactivity is common in young adult cancer survivors. However, few interventions have focused on helping young adult cancer survivors to get more physical activity. The IMproving Physical Activity after Cancer Treatment trial compared a mobile health physical activity intervention with a self-help group on total amount of physical activity at 6 months in a nationwide sample of young adult cancer survivors. Intervention participants did not improve their total amount of physical activity, but they did increase their moderate-to-vigorous intensity physical activity by twice as much as the self-help participants. This increase in activity may be associated with health benefits.

A cluster-randomized controlled trial of automated internet weight-loss programs in primary care: Role of automated provider feedback.

OBJECTIVE: Despite the high prevalence of obesity and associated health risks in the United States adult population, few primary care providers (PCPs) have time and training to provide weight-management counseling to their patients. This study aims to compare the effect of referral to a comprehensive automated digital weight-loss program, with or without provider email feedback, with usual care on weight loss in patients with overweight or obesity. METHODS: A total of 550 adults (mean [SD], 51.4 [11.2] years, BMI = 35.1 [5.5] kg/m2 , 72.0% female) were enrolled through their PCPs (n = 31). Providers were randomly assigned to refer their patients to a 12-month internet weight-loss intervention only (IWL), the intervention plus semiautomated feedback from the provider (IWL + PCP), or to usual care (EUC). Weight was measured at baseline and at 3, 6, and 12 months. RESULTS: Weight changes (mean [SE]) at 12 months were -0.92 (0.46), -3.68 (0.46), and -3.58 (0.48) kg in the EUC, IWL, and IWL + PCP groups, respectively. Outcomes were significantly different in EUC versus IWL and EUC versus IWL + PCP (p < 0.001), but not in IWL versus IWL + PCP. CONCLUSIONS: Referral by PCPs to an automated weight-loss program holds promise for patients with obesity. Future research should explore ways to further promote accountability and adherence.

Recruitment of young adult cancer survivors into a randomized controlled trial of an mHealth physical activity intervention.

PURPOSE: Few studies have recruited young adult cancer survivors (YACS) from around the USA into remotely-delivered behavioral clinical trials. This study describes recruitment strategies used in the IMproving Physical Activity after Cancer Treatment (IMPACT) study, a 12-month randomized controlled trial of a mobile physical activity intervention for YACS. METHODS: We conducted formative work to guide development of recruitment messages and used a variety of methods and channels to recruit posttreatment YACS (diagnosed ages 18-39, participating in < 150 min/week of moderate-to-vigorous intensity activity). We used targeted social media advertisements, direct mailings, clinical referrals, and phone calls to potentially eligible individuals identified through local tumor registries. We also asked community organizations to share study information and advertized at a national conference for YACS. RESULTS: The final sample of 280 participants (23% identified as racial/ethnic minority individuals, 18% male, mean 33.4 ± 4.8 years) was recruited over a 14-month period. About 38% of those who completed initial screening online (n = 684) or via telephone (n = 63) were randomized. The top recruitment approach was unpaid social media, primarily via Facebook posts by organizations/friends (45%), while direct mail yielded 40.7% of participants. Other social media (paid advertisements, Twitter), email, clinic referrals, and conference advertisements each yielded 3% or fewer participants. The most cost-effective methods per participant recruited were unpaid social media posts and direct mailings. CONCLUSIONS: The IMPACT trial successfully met enrollment goals using a national strategy to recruit physically inactive YACS. Our approaches can inform recruitment planning for other remotely-delivered intervention trials enrolling YACS. TRIAL REGISTRATION: ClinicalTrials.gov NCT03569605 . Registered on 26 June 2018.

Behavioral weight loss in emerging adults: Design and rationale for the Richmond Emerging Adults Choosing Health (REACH) randomized clinical trial.

BACKGROUND: In the U.S., over 40% of 18-25 year olds meet criteria for overweight or obesity. Yet, no large-scale trials have targeted this age group for behavioral weight loss (BWL). Formative data revealed that existing BWL programs do not meet their unique needs and identified motivation as a fundamental barrier for weight management. The goal of the Richmond Emerging Adults Choosing Health (REACH) trial was to test the efficacy of two mHealth lifestyle interventions specifically focused on enhancing motivation, relative to adapted standard. METHODS: Participants (N = 381, 18-25 years, body mass index 25-45 kg/m2) will be randomized to 1) adapted BWL (aBWL), 2) aBWL + self-determination theory (aBWL+SDT), or 3) aBWL + behavioral economics (aBWL+BE). All arms will receive a 6-month intervention, delivered via one group session and one individual session, followed by an mHealth platform. Assessments will occur at baseline, 3-months, 6-months (post-treatment) and 12-months (following a no-contact period). The primary aim is to compare weight loss outcomes at 6 months. Secondary aims include changes at 6-months in physical and behavioral cardiometabolic risk factors, as well as psychosocial measures. We will also explore weight loss maintenance, change in hypothesized mediators, and moderators of treatment response. DISCUSSION: REACH is the first large-scale BWL trial designed specifically for emerging adults. Further, it will be the first trial to compare a lifestyle intervention grounded in self-determination theory to one rooted in behavioral economics. If clinically significant reductions in adiposity are achieved, findings could inform a scalable treatment model to meet the needs of this vulnerable population. TRIAL REGISTRATION: NCT02736981.

Promoting physical activity in young adult cancer survivors using mHealth and adaptive tailored feedback strategies: Design of the Improving Physical Activity after Cancer Treatment (IMPACT) randomized controlled trial.

INTRODUCTION: Despite the health benefits of physical activity for cancer survivors, nearly 60% of young adult cancer survivors (YACS) are physically inactive. Few physical activity interventions have been designed specifically for YACS. PURPOSE: To describe the rationale and design of the IMPACT (IMproving Physical Activity after Cancer Treatment) trial, which tests the efficacy of a theory-based, mobile physical activity intervention for YACS. METHODS: A total of 280 physically inactive YACS (diagnosed at ages 18-39) will be randomized to a self-help control or intervention condition. All participants will receive an activity tracker and companion mobile app, cellular-enabled scale, individual videochat session, and access to a Facebook group. Intervention participants will also receive a 6-month mobile intervention based on social cognitive theory, which targets improvements in behavioral capability, self-regulation, self-efficacy, and social support, and incorporates self-regulation strategies and behavior change techniques. The program includes: behavioral lessons; adaptive goal-setting in response to individuals' changing activity patterns; tailored feedback based on objective data and self-report measures; tailored text messages; and Facebook prompts encouraging peer support. Assessments occur at baseline, 3, 6, and 12 months. The primary outcome is total physical activity min/week at 6 months (assessed via accelerometry); secondary outcomes include total physical activity at 12 months, sedentary behavior, weight, and psychosocial measures. CONCLUSIONS: IMPACT uniquely focuses on physical activity in YACS using an automated tailored mHealth program. Study findings could result in a high-reach, physical activity intervention for YACS that has potential to be adopted on a larger scale and reduce cancer-related morbidity. ClinicalTrials.gov Identifier: NCT03569605.

Examination of a partial dietary self-monitoring approach for behavioral weight management.

INTRODUCTION: Dietary self-monitoring in behavioral weight loss programmes traditionally involves keeping track of all foods and beverages to achieve a calorie deficit. While effective, adherence declines over time. WW™ (formerly Weight Watchers), a widely available commercial weight management programme, sought to pilot an approach that permitted participants to consume over 200 foods without monitoring them. METHODS: The current study used a pre-post evaluation design with anthropometric, psychosocial and physical health assessments at baseline, 3 and 6 months. RESULTS: Participants (N = 152) were, on average, 48.4 (±12.3) years old, with body mass index (BMI) of 32.8 (±4.8) m/kg2 and 94% female. Mean weight loss was 6.97 + 5.55 kg or 7.9 ± 6.1% of initial body weight (ps < .0001) at 6 months. One third (32.6%) of the sample lost 10% or more of initial body weight. Significant improvements in hunger, cravings, happiness, sleep, quality of life, aerobic stamina, flexibility and blood pressure were observed. Attendance at group meetings, as well as decreases in hunger, and fast food cravings from baseline to 3 months were associated with achieving 10% weight loss at 6 months (p < .01). CONCLUSIONS: Using an approach that does not require self-monitoring of all foods and beverages produced significant weight losses and other physical and psychosocial improvements.

Deconstructing Weight Management Interventions for Young Adults: Looking Inside the Black Box of the EARLY Consortium Trials.

OBJECTIVE: The goal of the present study was to deconstruct the 17 treatment arms used in the Early Adult Reduction of weight through LifestYle (EARLY) weight management trials. METHODS: Intervention materials were coded to reflect behavioral domains and behavior change techniques (BCTs) within those domains planned for each treatment arm. The analytical hierarchy process was employed to determine an emphasis profile of domains in each intervention. RESULTS: The intervention arms used BCTs from all of the 16 domains, with an average of 29.3 BCTs per intervention arm. All 12 of the interventions included BCTs from the six domains of Goals and Planning, Feedback and Monitoring, Social Support, Shaping Knowledge, Natural Consequences, and Comparison of Outcomes; 11 of the 12 interventions shared 15 BCTs in common across those six domains. CONCLUSIONS: Weight management interventions are complex. The shared set of BCTs used in the EARLY trials may represent a core intervention that could be studied to determine the required emphases of BCTs and whether additional BCTs add to or detract from efficacy. Deconstructing interventions will aid in reproducibility and understanding of active ingredients.

Randomized trial comparing group size of periodic in-person sessions in a remotely delivered weight loss intervention.

BACKGROUND: Few randomized studies have examined differential effects of group size in behavioral weight control, especially in hybrid programs that include Internet treatment approaches. METHODS: Randomized controlled trial (n = 195) comparing a 4 month hybrid internet weight loss program coupled with monthly face to face groups of 100 persons (Large Group, LG; 1 group) or to the same approach with monthly groups of 20 persons (Small Group, SG; 4 groups). Repeated-measures mixed-model analysis with age and race as covariates were used to estimate primary (weight) and secondary outcomes, and to test group differences in change over time. RESULTS: The sample was 46.3 years old ±10.4, 90.3% female, and 51.9% non-white, with BMI 37.9 ± 8.4 kg/m2. Participants in the LG were more likely to return for the 4-month assessment visit than those in the SG (p = 0.04). Participants randomized to both the LG and SG conditions experienced significant WL over time (no between group difference: -4.1 kg and -3.7 kg, respectively) and weight loss was positively associated with attendance at monthly meetings and logins to the website. Satisfaction with the program was high and similar in both groups (94.4% reported that they were "satisfied" or "very satisfied"). CONCLUSIONS: Using a hybrid approach of in-person and online weight loss interventions may be an effective way to reach larger and more diverse populations. Delivering the face to face component of the intervention in groups larger than those traditionally delivered (20-25 people) could increase the cost-effectiveness of group-based behavioral weight loss interventions. CLINICAL TRIALS REGISTRATION NUMBER: NCT01615471 . Registered June 6, 2012. Registered retrospectively.

Acculturation Influences Postpartum Eating, Activity, and Weight Retention in Low-Income Hispanic Women.

BACKGROUND: Low-income Hispanic women experience elevated rates of high postpartum weight retention (PPWR), which is an independent risk factor for lifetime obesity. Sociocultural factors might play an important role among Hispanic women; however, very few studies have examined this association. OBJECTIVE: The purpose of our study was to examine the associations between acculturation and maternal diet, physical activity, and PPWR. DESIGN: This is a cross-sectional study of baseline data from 282 Hispanic women participating in the FitMoms/Mamás Activas study, a randomized controlled trial examining the impact of primarily an internet-based weight control program, in reducing PPWR among low-income women. We performed multivariable linear regression to examine the association of acculturation with diet quality, physical activity, and PPWR at study entry. RESULTS: A total of 213 (76%) women had acculturation scores reflecting Mexican orientation or bicultural orientation, whereas 69 (24%) had scores that represented assimilation to Anglo culture. Women who were more acculturated had lower intakes of fruits and vegetables, lower HEI scores, and lower physical activity levels than women who were less acculturated (p < 0.05). We found an association between acculturation and PPWR in that for every 1-unit increase in acculturation score, PPWR increased, on average, by 0.80 kg. CONCLUSION: Higher acculturation was associated with poorer diet and physical activity behaviors and greater PPWR.

The Gestational Diabetes Management System (GooDMomS): development, feasibility and lessons learned from a patient-informed, web-based pregnancy and postpartum lifestyle intervention.

BACKGROUND: Gestational diabetes mellitus (GDM) contributes to the epidemic of diabetes and obesity in mothers and their offspring. The primary objective of this pilot study was to: 1) refine the GDM Management System (GooDMomS), a web-based pregnancy and postpartum behavioral intervention and 2) assess the feasibility of the intervention. METHODS: In phase 1, ten semi-structured interviews were conducted with women experiencing current or recent GDM mellitus GDM to garner pilot data on the web based intervention interface, content, and to solicit recommendations from women about refinements to enhance the GooDMomS intervention site. Interviews were audiotaped, transcribed and independently reviewed to identify major themes with Atlas.ti v7.0. In phase 2, a single-arm feasibility study was conducted and 23 participants were enrolled in the GooDMomS program. Participants received web lessons, self-tracking of weight and glucose, automated feedback and access to a message board for peer support. The primary outcome was feasibility, including recruitment and retention and acceptability. Secondary outcomes included the proportion of women whose gestational weight gain (GWG) was within the Institute of Medicine (IOM) guidelines and who were able to return to their pre-pregnancy weight after delivery. RESULTS: Comments from semi-structured interviews focused on: 1) usability of the on-line self-monitoring diary and tracking system, 2) access to a safe, reliable social network for peer support and 3) ability of prenatal clinicians to access the on-line diary for clinical management. Overall, 21 (91 %) completed the pregnancy phase. 15/21 (71 %) of participants were within the Institute of Medicine (IOM) guidelines for GWG. Sixteen (70 %) completed the postpartum phase. 7/16 (43 %) and 9/16 (56 %) of participants returned to their pre-pregnancy weight at 6 and 30 weeks postpartum, respectively. CONCLUSIONS: This study documents the feasibility of the GooDMomS program. The results can have implications for web technology in perinatal care and inform the current care paradigm for women with GDM. Findings are supportive of further research with recruitment of a larger sample of participants and comparison of the outcomes with the intervention and standard care. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov on May 15, 2012 under protocol no. NCT01600534 .

'Fit Moms/Mamás Activas' internet-based weight control program with group support to reduce postpartum weight retention in low-income women: study protocol for a randomized controlled trial.

BACKGROUND: High postpartum weight retention is a strong independent risk factor for lifetime obesity, cardiovascular disease, and type 2 diabetes in women. Interventions to promote postpartum weight loss have met with some success but have been limited by high attrition. Internet-based treatment has the potential to overcome this barrier and reduce postpartum weight retention, but no study has evaluated the effects of an internet-based program to prevent high postpartum weight retention in women. METHODS/DESIGN: Fit Moms/Mamás Activas targets recruitment of 12 Women, Infants and Children (WIC) Supplemental Nutrition Program clinics with a total of 408 adult (>18 years), postpartum (<1 year) women with 14.5 kg or more weight retention or a body mass index of 25.0 kg/m(2) or higher. Clinics are matched on size and randomly assigned within county to either a 12-month standard WIC intervention or to a 12-month WIC enhanced plus internet-based weight loss intervention. The intervention includes: monthly face-to-face group sessions; access to a website with weekly lessons, a web diary, instructional videos, and computer-tailored feedback; four weekly text messages; and brief reinforcement from WIC counselors. Participants are assessed at baseline, six months, and 12 months. The primary outcome is weight loss over six and 12 months; secondary outcomes include diet and physical activity behaviors, and psychosocial measures. DISCUSSION: Fit Moms/Mamás Activas is the first study to empirically examine the effects of an internet-based treatment program, coupled with monthly group contact at the WIC program, designed to prevent sustained postpartum weight retention in low-income women at high risk for weight gain, obesity, and related comorbidities. TRIAL REGISTRATION: This trial was registered with Clinicaltrials.gov (identifier: NCT01408147 ) on 29 July 2011.

Replacing caloric beverages with water or diet beverages for weight loss in adults: main results of the Choose Healthy Options Consciously Everyday (CHOICE) randomized clinical trial.

BACKGROUND: Replacement of caloric beverages with noncaloric beverages may be a simple strategy for promoting modest weight reduction; however, the effectiveness of this strategy is not known. OBJECTIVE: We compared the replacement of caloric beverages with water or diet beverages (DBs) as a method of weight loss over 6 mo in adults and attention controls (ACs). DESIGN: Overweight and obese adults [n = 318; BMI (in kg/m(2)): 36.3 ± 5.9; 84% female; age (mean ± SD): 42 ± 10.7 y; 54% black] substituted noncaloric beverages (water or DBs) for caloric beverages (≥200 kcal/d) or made dietary changes of their choosing (AC) for 6 mo. RESULTS: In an intent-to-treat analysis, a significant reduction in weight and waist circumference and an improvement in systolic blood pressure were observed from 0 to 6 mo.Mean ((±SEM) weight losses at 6 mo were -2.5 ± 0.45% in the DB group, -2.03 ± 0.40% in the water group, and -1.76 ± 0.35% in the AC group; there were no significant differences between groups [corrected]. The chance of achieving a 5% weight loss at 6 mo was greater in the DB group than in the AC group (OR: 2.29; 95% CI: 1.05, 5.01; P = 0.04). A significant reduction in fasting glucose at 6 mo (P = 0.019) and improved hydration at 3 (P = 0.0017) and 6 (P = 0.049) mo was observed in the Water group relative to the AC group. In a combined analysis, participants assigned to beverage replacement were 2 times as likely to have achieved a 5% weight loss (OR: 2.07; 95% CI: 1.02, 4.22; P = 0.04) than were the AC participants. CONCLUSIONS: Replacement of caloric beverages with noncaloric beverages as a weight-loss strategy resulted in average weight losses of 2% to 2.5%. This strategy could have public health significance and is a simple, straightforward message. This trial was registered at clinicaltrials.gov as NCT01017783.