Weight Loss Experiences of African American, Hispanic, and Non-Hispanic White Men and Women with Type 2 Diabetes: The Look AHEAD Trial.

OBJECTIVE: The aim of this study was to characterize weight loss, treatment engagement, and weight control strategies utilized by African American, Hispanic, and non-Hispanic white participants in the Action for Health in Diabetes (Look AHEAD) Intensive Lifestyle Intervention by racial/ethnic and sex subgroups. METHODS: Weight losses at 1, 4, and 8 years among 2,361 adults with obesity and type 2 diabetes randomized to intervention (31% minority; 42% men) are reported by subgroup. Multivariable models within subgroups examine relative contributions of treatment engagement variables and self-reported weight control behaviors. RESULTS: All subgroups averaged weight losses ≥ 5% in year 1 but experienced regain; losses ≥ 5% were sustained at year 8 by non-Hispanic white participants and minority women (but not men). Session attendance was high (≥ 86%) in year 1 and exceeded protocol-specified minimum levels into year 8. Individual session attendance had stronger associations with weight loss among Hispanic and African American participants than non-Hispanic white participants at 4 years (P = 0.04) and 8 years (P = 0.001). Daily self-weighing uptake was considerable in all subgroups and was a prominent factor associated with year 1 weight loss among African American men and women. Greater meal replacement use was strongly associated with poorer 1-year weight losses among African American women. CONCLUSIONS: Experiences of minority men and women with diabetes in lifestyle interventions fill important gaps in the literature that can inform treatment delivery.

Effect of Wearable Technology Combined With a Lifestyle Intervention on Long-term Weight Loss: The IDEA Randomized Clinical Trial.

Importance: Effective long-term treatments are needed to address the obesity epidemic. Numerous wearable technologies specific to physical activity and diet are available, but it is unclear if these are effective at improving weight loss. Objective: To test the hypothesis that, compared with a standard behavioral weight loss intervention (standard intervention), a technology-enhanced weight loss intervention (enhanced intervention) would result in greater weight loss. Design, Setting, Participants: Randomized clinical trial conducted at the University of Pittsburgh and enrolling 471 adult participants between October 2010 and October 2012, with data collection completed by December 2014. Interventions: Participants were placed on a low-calorie diet, prescribed increases in physical activity, and had group counseling sessions. At 6 months, the interventions added telephone counseling sessions, text message prompts, and access to study materials on a website. At 6 months, participants randomized to the standard intervention group initiated self-monitoring of diet and physical activity using a website, and those randomized to the enhanced intervention group were provided with a wearable device and accompanying web interface to monitor diet and physical activity. Main Outcomes and Measures: The primary outcome of weight was measured over 24 months at 6-month intervals, and the primary hypothesis tested the change in weight between 2 groups at 24 months. Secondary outcomes included body composition, fitness, physical activity, and dietary intake. Results: Among the 471 participants randomized (body mass index [BMI], 25 to <40; age range, 18-35 years; 28.9% nonwhite, 77.2% women), 470 (233 in the standard intervention group, 237 in the enhanced intervention group) initiated the interventions as randomized, and 74.5% completed the study. For the enhanced intervention group, mean base line weight was 96.3 kg (95% CI, 94.2-98.5) and 24-month weight 92.8 kg (95% CI, 90.6- 95.0) [corrected]. For the standard intervention group, mean baseline weight was 95.2kg (95%CI,93.0-97.3)and24-month weight was 89.3 kg (95%CI, 87.1-91.5) [corrected]. Weight change at 24 months differed significantly by intervention group (estimated mean weight loss, 3.5 kg [95% CI, 2.6-4.5} in the enhanced intervention group and 5.9 kg [95% CI, 5.0-6.8] in the standard intervention group; difference, 2.4 kg [95% CI, 1.0-3.7]; P = .002). Both groups had significant improvements in body composition, fitness, physical activity, and diet, with no significant difference between groups. Conclusions and Relevance: Among young adults with a BMI between 25 and less than 40, the addition of a wearable technology device to a standard behavioral intervention resulted in less weight loss over 24 months. Devices that monitor and provide feedback on physical activity may not offer an advantage over standard behavioral weight loss approaches. Trial Registration: clinicaltrials.gov Identifier: NCT01131871.

The Effect of Self-Efficacy on Behavior and Weight in a Behavioral Weight-Loss Intervention.

OBJECTIVE: To determine whether eating self-efficacy (ESE) and physical activity self-efficacy (PASE) are predictive of dietary intake, physical activity, and weight change within a behavioral weight-loss intervention, and whether dietary intake and physical activity mediate relationships between self-efficacy and weight change. METHOD: The study sample included 246 participants from a randomized trial with complete data on study variables at 12 months. ESE, PASE, calories consumed, minutes of moderate-to-vigorous physical activity (MVPA), and weight were measured at baseline, 6, and 12 months. RESULTS: ESE at baseline was associated with 12-month percent weight loss (PWL), and was mediated by average calories consumed at 6 and 12 months. Change in ESE from baseline to 6 months was associated with calories consumed at 12 months and 12-month percent weight loss, but the mediated relationship was not significant. Baseline PASE was not associated with average MVPA at 6 and 12 months or 12-month PWL, but change in PASE from baseline to 6 months was associated with 12-month PWL through its effect on MVPA at 12 months. CONCLUSION: Increases in ESE and PASE during the active phase of the intervention are predictive of dietary intake, physical activity and weight loss at later points, but further research should include explorations of the reciprocal relationship between behavior and self-efficacy to better inform intervention strategies that target self-efficacy and promote behavior change. (PsycINFO Database Record

Short-term weight loss with diet and physical activity in young adults: The IDEA study.

OBJECTIVE: This study examined the effect of a behavioral weight loss intervention (BWLI) on young adults (age = 18-35 years). METHODS: Participants (N = 470) enrolled in a 6-month BWLI that included weekly group sessions, a prescribed energy-restricted diet, and moderate to vigorous physical activity (MVPA). Assessments included weight, body composition, fitness, lipids, glucose, insulin, resting blood pressure and heart rate, physical activity, and dietary intake. Data are presented as median [25th, 75th percentiles]. RESULTS: Retention was 90% (N = 424; age: 30.9 [27.8, 33.7] years; BMI: 31.2 [28.4, 34.3] kg m(-2) ). Participants completed 87.5% [76.1%, 95.5%] of scheduled intervention contacts. Weight and body fat decreased while fitness increased (P < 0.0001). MVPA in bouts ≥10 min increased (P < 0.0001), though total MVPA did not change significantly. Sedentary time decreased (P = 0.03). Energy and percent fat intake decreased, while percent carbohydrate and protein intake increased (P < 0.0001). Systolic and diastolic blood pressure, total cholesterol, LDL cholesterol, triglycerides, glucose, and insulin decreased (P < 0.0001). CONCLUSIONS: A 6-month BWLI produced favorable changes in dietary intake and physical activity and elicited favorable changes in weight and other health outcomes in young adults. MVPA performed in bouts of ≥10 min was associated with greater weight loss, but sedentary behavior was not.

Racial Differences in Weight Loss Among Adults in a Behavioral Weight Loss Intervention: Role of Diet and Physical Activity.

BACKGROUND: African-Americans lose less weight during a behavioral intervention compared with Whites, which may be from differences in dietary intake or physical activity. METHODS: Subjects (30% African American, 70% White; n = 346; 42.4 ± 9.0 yrs.; BMI = 33.0 ± 3.7 kg/m2) in an 18-month weight loss intervention were randomized to a standard behavioral (SBWI) or a stepped-care (STEP) intervention. Weight, dietary intake, self-report and objective physical activity, and fitness were assessed at 0, 6, 12, and 18 months. RESULTS: Weight loss at 18 months was greater in Whites (-8.74 kg with 95% CI [-10.10, -7.35]) compared with African Americans (-5.62 kg with 95% CI [-7.86, -3.37]) (P = .03) in the SBWI group and the STEP group (White: -7.48 kg with 95% CI [-8.80, -6.17] vs. African American: -4.41kg with 95% CI [-6.41, -2.42]) (P = .01). Patterns of change in dietary intake were not different between groups. Objective physical activity (PA) changed over time (P < .0001) and was higher in Whites when compared with African Americans (P = .01). CONCLUSIONS: Whites lost more weight (3.10 kg) than African American adults. Although there were no differences in dietary intake, Whites had higher levels of objective PA and fitness. Thus, the discrepancy in weight loss may be due to differences in PA rather than dietary intake. However, the precise role of these factors warrants further investigation.

Objective vs. Self-report Sedentary Behavior in Overweight and Obese Young Adults.

BACKGROUND: Sedentary behavior (SED) has been measured almost exclusively by self-reported total SED or television time in longitudinal studies. This manuscript aimed to compare self-reported vs. objectively measured SED. METHODS: Among overweight and obese young adults enrolled in a weight loss trial, baseline SED was assessed by 3 methods: 1) a questionnaire assessing 8 common SEDs (SEDQ), 2) 1 question assessing SED from the Global Physical Activity Questionnaire (SEDGPAQ), and 3) a monitor worn on the arm (SEDOBJ). In addition, television time (SEDTV) was isolated from the SEDQ. SED measures were compared using Spearman's correlations, signed-rank tests, and Bland-Altman plots. RESULTS: In 448 participants, SEDQ and SEDGPAQ were only weakly associated with SEDOBJ (rs = 0.21; P < .001, rs = 0.32; P < .001, respectively). Compared with SEDOBJ, SEDQ more often overestimated SEDOBJ (median difference: 1.1 hours/day; P < .001), while SEDGPAQ more often underestimated SEDOBJ (median difference: -0.7 hours/day; P < .001). The correlation between SEDTV and SEDOBJ was not significantly different from 0 (rs = 0.08; P = .08). CONCLUSIONS: SEDQ and SEDGPAQ were weakly correlated with, and significantly different from, SEDOBJ in overweight and obese young adults. SEDTV was not related to SEDOBJ. The poor associations of self-reported and objectively measured SED could affect interpretation and comparison across studies relating SED to adverse health outcomes.

Objective Versus Self-Reported Physical Activity in Overweight and Obese Young Adults.

BACKGROUND: To compare moderate-to-vigorous intensity physical activity (MVPA) assessed via questionnaires to an objective measure of MVPA in overweight or obese young adults. METHODS: MVPA was assessed in 448 [median BMI = 31.2 (Interquartile Range: 28.5-34.3) kg/m2] young adults [median age: 30.9 (Interquartile Range: 27.8-33.7) years]. Measures included the SenseWear Armband (MVPAOBJ), the Paffenbarger Questionnaire (MVPAPAFF), and the Global Physical Activity Questionnaire (GPAQ). The GPAQ was used to compute total MVPA (MVPAGPAQ-TOTAL) and MVPA from transportation and recreation (MVPAGPAQ-REC). RESULTS: The association between MVPAOBJ and MVPAPAFF was rs = 0.40 (P < .0001). Associations between MVPAOBJ and MVPAGPAQ-TOTAL and MVPAGPAQ-REC were rs = 0.19 and rs = 0.32, respectively (P < .0001). MVPAGPAQ-TOTAL was significantly greater than MVPAOBJ (P < .0001). Median differences in MET-min/week between MVPAOBJ and MVPAPAFF or MVPAGPAQ-REC were not significantly different from zero. There was proportional bias between each self-reported measure of MVPA and MVPAOBJ. There were significant associations between all measures of MVPA and fitness. MVPAOBJ was significantly associated with BMI and percent body fat. CONCLUSIONS: Objective and self-reported measures of MVPA are weakly to moderately correlated, with substantial differences between measures. MVPAOBJ provided predictive validity with fitness, BMI, and percent body fat. Thus, an objective measure of MVPA may be preferred to self-report in young adults.

Time-based physical activity interventions for weight loss: a randomized trial.

PURPOSE: This study aims to examine whether enhancing standard behavioral weight loss interventions (standard behavioral weight loss program (SBWP)) with additional strategies at the initiation of intervention (ADOPT) or providing the additional strategies at predetermined times over the intervention period (MAINTAIN) enhances 18-month weight loss. METHODS: This was a clinical trial of participants (N = 195; mean ± SEM: age, 43.2 ± 8.6 yr; body mass index, 33.0 ± 3.4 kg·m) randomized to SBWP, ADOPT, or MAINTAIN. All participants were prescribed an energy-restricted diet and physical activity, with group intervention sessions delivered over 18 months. ADOPT participants received additional phone contact (months 1-3), supervised exercise (months 1-6), and behavior campaigns (months 4-9). MAINTAIN participants received additional phone contact (months 4-6), supervised exercise (months 7-12), and behavior campaigns (months 13-18). RESULTS: There was a significant group-time interaction for weight loss (P = 0.0032). SBWP participants lost 9.3 ± 0.9, 7.8 ± 1.1, and 5.9 ± 1.2 kg at 6, 12, and 18 months, respectively. ADOPT participants lost 8.9 ± 0.9, 7.6 ± 1.2, and 5.8 ± 1.2 kg, whereas MAINTAIN participants lost 9.7 ± 0.9, 11.0 ± 1.2, and 9.0 ± 1.2 kg at 6, 12, and 18 months, respectively. The group-time interactions for SBWP versus MAINTAIN (P = 0.0033) and for ADOPT versus MAINTAIN (P = 0.0075) were significant. There was a significant group-time interaction for change in fitness (P = 0.0060). The group-time interaction for MAINTAIN versus ADOPT (P = 0.0018) was significant, with a trend for MAINTAIN versus SBWP (P = 0.0525). CONCLUSIONS: MAINTAIN improves 18-month weight loss compared with SBWP and ADOPT, with statistical trends indicating that MAINTAIN results in greater improvements in fitness. These results suggest that time-based strategies emphasizing physical activity confer greater benefits when delivered later and over the full course of intervention. This provides valuable information for the implementation of time-based strategies for improving long-term weight loss and fitness in overweight and obese adults.

Objective physical activity and weight loss in adults: the step-up randomized clinical trial.

OBJECTIVE: To examine the amount of objectively measured MVPA and LPA that is associated with long-term weight loss and the maintenance of clinically significant weight loss. METHODS: Adults (N = 260; BMI: 25 to <40 kg/m(2) ; age: 18-55 years) participated in an 18-month behavioral weight loss intervention and were prescribed a low-calorie diet and increased physical activity. Change in weight and objectively measured physical activity were assessed. MVPA > 10 (MET-min/week) was computed from bouts >10 min and >3.0 METs and MVPA < 10 was computed from bouts <10 min in duration and >3.0 METs. LPA was computed from bouts between 1.5 to <3.0 METs. RESULTS: When grouped on percent weight loss at 18 months, there was a significant group × time interaction effect (P < 0.0001) for both MVPA > 10 and LPA, with both measures being significantly greater at 18 months in those with >10% weight loss. Similar results were observed for MVPA > 10 and LPA with participants grouped on achieving >10% weight loss at 6 months and sustaining this at 18 months. CONCLUSIONS: MVPA > 10 of 200-300 min per week, coupled with increased amounts of LPA, are associated with improved long-term weight loss. Interventions should promote engagement in these amounts and types of physical activity.

Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes.

BACKGROUND: Weight loss is recommended for overweight or obese patients with type 2 diabetes on the basis of short-term studies, but long-term effects on cardiovascular disease remain unknown. We examined whether an intensive lifestyle intervention for weight loss would decrease cardiovascular morbidity and mortality among such patients. METHODS: In 16 study centers in the United States, we randomly assigned 5145 overweight or obese patients with type 2 diabetes to participate in an intensive lifestyle intervention that promoted weight loss through decreased caloric intake and increased physical activity (intervention group) or to receive diabetes support and education (control group). The primary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for angina during a maximum follow-up of 13.5 years. RESULTS: The trial was stopped early on the basis of a futility analysis when the median follow-up was 9.6 years. Weight loss was greater in the intervention group than in the control group throughout the study (8.6% vs. 0.7% at 1 year; 6.0% vs. 3.5% at study end). The intensive lifestyle intervention also produced greater reductions in glycated hemoglobin and greater initial improvements in fitness and all cardiovascular risk factors, except for low-density-lipoprotein cholesterol levels. The primary outcome occurred in 403 patients in the intervention group and in 418 in the control group (1.83 and 1.92 events per 100 person-years, respectively; hazard ratio in the intervention group, 0.95; 95% confidence interval, 0.83 to 1.09; P=0.51). CONCLUSIONS: An intensive lifestyle intervention focusing on weight loss did not reduce the rate of cardiovascular events in overweight or obese adults with type 2 diabetes. (Funded by the National Institutes of Health and others; Look AHEAD ClinicalTrials.gov number, NCT00017953.).

Effect of a stepped-care intervention approach on weight loss in adults: a randomized clinical trial.

CONTEXT: Given the obesity epidemic, effective but resource-efficient weight loss treatments are needed. Stepped-treatment approaches customize interventions based on milestone completion and can be more effective while costing less to administer than conventional treatment approaches. OBJECTIVE: To determine whether a stepped-care weight loss intervention (STEP) compared with a standard behavioral weight loss intervention (SBWI) would result in greater weight loss. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial of 363 overweight and obese adults (body mass index: 25-<40; age: 18-55 years, 33% nonwhite, and 83% female) who were randomized to SBWI (n = 165) or STEP (n = 198) at 2 universities affiliated with academic medical centers in the United States (Step-Up Study). Participants were enrolled between May 2008 and February 2010 and data collection was completed by September 2011. INTERVENTIONS: All participants were placed on a low-calorie diet, prescribed increases in physical activity, and attended group counseling sessions ranging from weekly to monthly during an 18-month period. The SBWI group was assigned to a fixed program. Counseling frequency, type, and weight loss strategies could be modified every 3 months for the STEP group in response to observed weight loss as it related to weight loss goals. MAIN OUTCOME MEASURE: Mean change in weight over 18 months. Additional outcomes included resting heart rate and blood pressure, waist circumference, body composition, fitness, physical activity, dietary intake, and cost of the program. RESULTS: Of the 363 participants randomized, 260 (71.6%) provided a measure of mean change in weight over 18 months. The 18-month intervention resulted in weight decreasing from 93.1 kg (95% CI, 91.0 to 95.2 kg) to 85.6 kg (95% CI, 83.4 to 87.7 kg) (P < .001) in the SBWI group and from 92.7 kg (95% CI, 90.8 to 94.6 kg) to 86.4 kg (95% CI, 84.5 to 88.4 kg) in the STEP group (P < .001). The percentage change in weight from baseline to 18 months was -8.1% (95% CI, -9.4% to -6.9%) in the SBWI group (P < .001) compared with -6.9% (95% CI, -8.0% to -5.8%) in the STEP group (P < .001). Although the between-group difference in 18-month weight loss was not statistically different (-1.3 kg [95% CI, -2.8 to 0.2 kg]; P = .09), there was a significant group × time interaction effect (P = .03). The cost per participant was $1357 (95% CI, $1272 to $1442) for the SBWI group vs $785 (95% CI, $739 to $830) for the STEP group (P < .001). Both groups had significant and comparable improvements in resting heart rate, blood pressure level, and fitness. CONCLUSIONS: Among overweight and obese adults, the use of SBWI resulted in a greater mean weight loss than STEP over 18 months. Compared with SBWI, STEP resulted in clinically meaningful weight loss that cost less to implement. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00714168.

Patterns of weight change associated with long-term weight change and cardiovascular disease risk factors in the Look AHEAD Study.

This article provides an assessment of the associations that weight-loss patterns during the first year of an intensive lifestyle intervention have with 4-year maintenance and health outcomes. Two components described patterns of weight change during the first year of intervention: one reflected the typical pattern of weight loss over the 12 months, but distinguished those who lost larger amounts across the monthly intervals from those who lost less. The second component reflected the weight change trajectory, and distinguished a pattern of initial weight loss followed by regain vs. a more sustained pattern of weight loss. Two thousand four hundred and thirty eight individuals aged 45-76 years with type 2 diabetes mellitus, who enrolled in the weight-loss intervention of a randomized clinical trial, were assigned scores according to how their weight losses reflected these patterns. Relationships these scores had with weight losses and health outcomes (glycosolated hemoglobin--hemoglobin A1c (HbA1c); systolic blood pressure, high-density lipoprotein (HDL)-cholesterol, and triglycerides) over 4 years were described. When compared to those with lower scores on the two components, both individuals who had larger month-to-month weight losses in year 1 and whose weight loss was more sustained during the first year had better maintenance of weight loss over 4 years, independent of characteristics traditionally linked to weight loss success (P < 0.001). While relationships with year 4 weight loss were stronger, the pattern of larger monthly weight loss during year 1 was also independently predictive of year 4 levels of HbA1c, HDL-cholesterol, and systolic blood pressure.

The CALERIE Study: design and methods of an innovative 25% caloric restriction intervention.

Animal studies have shown that life span is extended by caloric restriction (CR). This manuscript describes the design and methodology of an innovative CR intervention, which is the treatment arm of the CALERIE Study. This study is a multi-center, randomized controlled trial examining the effects of 2 years of CR on biomarkers of longevity among non-obese (BMI ≥ 22 kg/m(2) and <28 kg/m(2)) adults. CALERIE is the first investigation of the effects of long-term CR on the aging process in non-obese humans. 220 healthy volunteers across 3 sites were recruited beginning in May 2007. Participants were randomized in a 2:1 ratio between the CR or control group (i.e., ad libitum diet). An intensive intervention was designed to assist participants in adhering to the 25% CR prescription for a two-year duration. The intervention was designed to optimize the likelihood that 25% CR would be achieved through a variety of nutritional and behavioral strategies, several of which are innovative methods for achieving CR. The intervention includes the following components: an intensive, "mixed" format schedule of group/individual sessions, meal provision phase with exposure to various diets, Personal Digital Assistants to monitor caloric intake, unique portion estimation training, tailored treatment using a computer tracking system, toolbox strategies and algorithms, as well as comprehensive coverage of nutrition and behavioral topics in order to assist participants in meeting their CR goal. This manuscript provides an overview of the CR intensive intervention and may be of assistance for other researchers and clinicians in designing future trials.