A small change approach to prevent long-term weight gain in adults with overweight and obesity: a randomized controlled trial

Background:Efforts to manage obesity through weight loss are often unsuccessful as most adults are not able to sustain the major changes in behaviour that are required to maintain weight loss long term. We sought to determine whether small changes in physical activity and diet prevent weight gain in adults with overweight and obesity.Methods:We randomized 320 sedentary adults with overweight or obesity to monitoring alone (MA, n = 160) or a small change approach (SCA, n = 160). In Phase I (2 yr), MA participants were asked to maintain their normal lifestyle and SCA participants were counselled to make small changes in diet and physical activity, namely a suggested increase in daily step count of 2000 steps with a decrease in energy intake of 100 kcal per day, with group and individual support. Phase II (1 yr) was a passive follow-up period. The difference in change in body weight between groups at 24 and 36 months from baseline was the primary outcome. Additional outcomes included waist circumference and cardiorespiratory fitness.Results:Overall, 268 participants (83.8%) completed the 2-year intervention, and 239 (74.7%) returned at the end of the follow-up period at 3 years. The difference in body weight change between the SCA and MA groups was significant at 3, 6, 12 and 15 months from baseline, but was no longer significant at 24 months (mean change 0.9 [standard error (SE) 0.5] kg v. −0.4 [SE 0.5] kg; difference −0.6, 95% confidence interval [CI] −1.9 to 0.8) or at 36 months (−1.2 [SE 0.8] v. −0.7 [SE 0.8] kg; difference −0.5, 95% CI −2.2 to 1.2). Changes in waist circumference and cardiorespiratory fitness were not significantly different between groups at 24 or 36 months (both p > 0.1).Interpretation:The SCA did not prevent weight gain compared with monitoring alone at 2 or 3 years in adults with overweight or obesity. On average, we observed prevention of weight gain in both arms of the trial. Trial registration:ClinicalTrials.gov, no. {"type":"clinical-trial","attrs":{"text":"NCT02027077","term_id":"NCT02027077"}}NCT02027077.

Overweight and obesity contribute to chronic diseases and present a major public health challenge¹ as more than 63% of adults in Canada currently live with overweight or obesity.² Despite the urgent need to address the obesity problem, few strategies designed to reduce obesity have been broadly successful.Results from randomized controlled trials show that most adults are not able to sustain the major changes in behaviour that are required to maintain weight loss long term.^3,4 A more reasonable and achievable goal may be to focus on the prevention of weight gain. Preventing further weight gain is clinically important as even modest weight gain (0.5–1.0 kg/yr) in adults with overweight and obesity has negative associations with adverse outcomes, such as cancer,⁵ all-cause and cardiovascular disease–related death⁶ and poor health-related quality of life.⁷It has been estimated that, for 90% of the adult population, a reduction of about 100–150 kcal/d would be required to prevent positive energy balance.^8,9 Two separate pilot studies have shown that a small change approach (SCA, defined as an increase in daily step count of 2000 steps or a decrease in energy intake of 100 kcal) prevented weight gain in a small group of adults and children with overweight over 13 weeks.^9,10 More recently SCA was shown to be associated with reduced weight gain in young adults with overweight at 2 years, compared with controls.¹¹We sought to determine the effectiveness of the SCA to prevent weight gain in adults with overweight (defined as a body mass index [BMI] 25–29.9) and obesity (defined as a BMI of ≥ 30) at 2 and 3 years. We hypothesized that the SCA would prevent weight gain in comparison with monitoring of body weight alone.     

Web-based weight management programs in an integrated health care setting: a randomized, controlled trial

Objective: To assess the efficacy of a Web‐based tailored behavioral weight management program compared with Web‐based information‐only weight management materials. Research Methods and Procedures: Participants, 2862 eligible overweight and obese (BMI = 27 to 40 kg/m²) members from four regions of Kaiser Permanente's integrated health care delivery system, were randomized to receive either a tailored expert system or information‐only Web‐based weight management materials. Weight change and program satisfaction were assessed by self‐report through an Internet‐based survey at 3‐ and 6‐month follow‐up periods. Results: Significantly greater weight loss at follow‐up was found among participants assigned to the tailored expert system than among those assigned to the information‐only condition. Subjects in the tailored expert system lost a mean of 3 ± 0.3% of their baseline weight, whereas subjects in the information‐only condition lost a mean of 1.2 ± 0.4% (p < 0.0004). Participants were also more likely to report that the tailored expert system was personally relevant, helpful, and easy to understand. Notably, 36% of enrollees were African‐American, with enrollment rates higher than the general proportion of African Americans in any of the study regions. Discussion: The results of this large, randomized control trial show the potential benefit of the Web‐based tailored expert system for weight management compared with a Web‐based information‐only weight management program.     

Vitamin D supplementation during rehabilitation in COPD: a secondary analysis of a randomized trial

Rationale

Pulmonary rehabilitation is an important treatment for patients with Chronic Obstructive Pulmonary Disease, who are often vitamin D deficient. As vitamin D status is linked to skeletal muscle function, we aimed to explore if high dose vitamin D supplementation can improve the outcomes of rehabilitation in Chronic Obstructive Pulmonary Disease.

Material and methods

This study is a post-hoc subgroup analysis of a larger randomized trial comparing a monthly dose of 100.000 IU of vitamin D with placebo to reduce exacerbations. 50 Subjects who followed a rehabilitation program during the trial are included in this analysis. We report changes from baseline in muscle strength and exercise performance between both study arms after 3 months of rehabilitation.

Results

Vitamin D intervention resulted in significantly higher median vitamin D levels compared to placebo (51 [44-62] ng/ml vs 15 [13-30] ng/ml; p < 0.001). Patients receiving vitamin D had significantly larger improvements in inspiratory muscle strength (-11±12 cmH2O vs 0±14 cmH2O; p = 0.004) and maximal oxygen uptake (110±211 ml/min vs -20±187 ml/min; p = 0.029). Improvements in quadriceps strength (15±16 Nm) or six minutes walking distance (40±55 meter) were not significantly different from the effects in the placebo group (7±19 Nm and 11±74 meter; p>0.050).

Conclusion

High dose vitamin D supplementation during rehabilitation may have mild additional benefits to training.     

Gender-equitable caregiver attitudes and education and safety of adolescent girls in South Kivu,DRC: A secondary analysis from a randomized controlled trial

BackgroundAdolescent girls face myriad threats to their well-being and safety as a result of gender-inequitable attitudes and norms, and these risks are often exacerbated during humanitarian emergencies. While humanitarian actors have begun to address caregivers’ behaviors and gender attitudes as an approach to support and meet the needs of adolescent girls, best practices for working with caregivers to improve adolescent girls’ well-being in these settings have yet to be identified.Methods and findingsThis study uses panel data from a program evaluation to analyze associations between changes in gender-equitable attitudes among caregivers and changes in schooling and violence victimization for girls ages 10 to 14 years old in the Democratic Republic of the Congo (DRC). Participants were recruited in May 2015 for baseline (May to July 2015) and endline (August to October 2016) data collection. Baseline and endline data for both caregivers and girls were available for 732 girls. The average ages of adolescents and caregivers were 12 and 40.7, respectively, and 92% of caregivers were female. The predictor of interest was the change in caregivers’ gender-equitable attitudes between the 2 points in time, where attitudes were measured using 10 underlying survey questions. The primary outcomes of interest were dichotomous and included improvement in schooling participation and declines in physical, sexual, and emotional violence and feeling uncared for. Logistic regression was used to estimate the association between changes in caregivers’ attitudes and 5 outcomes of interest and revealed that an increase in a caregiver’s gender-equitable attitude score was associated with significantly greater odds of a girl experiencing an improvement in schooling participation (aOR = 1.08, CI [1.005, 1.154], p = 0.036) and of a girl experiencing a marginal decline in physical violence victimization (aOR = 1.07, CI [0.989, 1.158], p = 0.092). Analyses also revealed that older girls had lower odds of experiencing an improvement in schooling participation (aOR = 0.77, CI [0.686, 0.861], p < 0.001), physical violence (aOR = 0.86, CI [0.757, 0.984], p = 0.028), sexual violence (aOR = 0.86, CI [0.743, 1.003], p = 0.055), or emotional violence (aOR = 0.98, CI [0.849, 1.105], p = 0.005). Important limitations in this study include the self-reported nature of outcomes, use of single questionnaire items to construct the outcome variables, and potential self-selection bias.ConclusionsResults suggest that supporting caregivers to increase gender equitable attitudes may be associated with benefits in dual outcomes of education and safety for adolescent girls in eastern DRC. Further research is needed to better understand how to induce a shift in these attitudes in multisectoral programming.Trial registration{"type":"clinical-trial","attrs":{"text":"NCT02384642","term_id":"NCT02384642"}}NCT02384642.

In an additional analysis of COMPASS intervention trial findings, Ilana Seff and colleagues study the associations between changes in gender attitudes among caregivers and violence victimization and schooling of adolescent girls in South Kivu, Democratic Republic of Congo.     

Estimating treatment effects from a randomized clinical trial in the presence of a secondary treatment

In randomized clinical trials involving survival time, a challenge that arises frequently, for example, in cancer studies (Manegold, Symanowski, Gatzemeier, Reck, von Pawel, Kortsik, Nackaerts, Lianes and Vogelzang, 2005. Second-line (post-study) chemotherapy received by patients treated in the phase III trial of pemetrexed plus cisplatin versus cisplatin alone in malignant pleural mesothelioma. Annals of Oncology 16, 923--927), is that subjects may initiate secondary treatments during the follow-up. The marginal structural Cox model and the method of inverse probability of treatment weighting (IPTW) have been proposed, originally for observational studies, to make causal inference on time-dependent treatments. In this paper, we adopt the marginal structural Cox model and propose an inferential method that improves the efficiency of the usual IPTW method by tailoring it to the setting of randomized clinical trials. The improvement in efficiency does not depend on any additional assumptions other than those required by the IPTW method, which is achieved by exploiting the knowledge that the study treatment is independent of baseline covariates due to randomization. The finite-sample performance of the proposed method is demonstrated via simulations and by application to data from a cancer clinical trial.     

Combining behavioral weight loss treatment and a commercial program: A randomized clinical trial

Objective:

To test the hypothesis that a novel weight loss approach that combined the fundamental components of professionally delivered behavioral weight loss (BWL) treatment with the existing Weight Watchers (WW) program would produce better weight losses than WW alone no differences were expected between the novel treatment and BWL alone.

Design and Methods:

Participants were 141 overweight and obese adults (90% women, 67% non‐White, mean age = 49.7 ± 9.2 years, mean body mass index = 36.2 ± 5.5 kg/m²) randomly assigned to 48 weeks of BWL, 48 weeks of WW, or 12 weeks of BWL followed by 36 weeks of WW [combined treatment (CT)]. Assessments were conducted at baseline and weeks 12, 24, and 48, with weight change as the primary outcome.

Results:

Linear mixed model analysis showed that 24‐week weight losses did not differ significantly between treatment groups; however, weight losses at 48 weeks were greater in the WW group (M = ?6.0 kg, standard error (SE) = 0.8) compared with the CT group (M = ?3.6 kg, SE = 0.8; P = 0.032), with BWL not significantly different from either (M = ?5.4 kg, SE = 0.8). Further, a greater proportion of WW participants lost 10% of baseline weight by 48 weeks compared with BWL or CT (36.7%, 13.0%, and 15.2%, respectively, P < 0.05).

Conclusion:

This study shows that the WW program can produce clinically meaningful weight losses and provides no evidence that adding brief BWL to the WW program improves outcome.

     

A randomized trial testing a contingency-based weight loss intervention involving social reinforcement

Even though behavioral weight loss interventions are conducted in groups, a social contingency (SC) paradigm that capitalizes on the social reinforcement potential of the weight loss group has never been tested. We tested a weight loss intervention in which participation in the weight loss group was contingent upon meeting periodic weight goals. We hypothesized that making access to the group dependent upon weight loss would improve weight outcomes. Participants (N = 62; 84% female; 94% white; age = 51.9 ± 9.0; BMI = 34.7 ± 4.5) were randomized to 6‐months of standard behavioral weight loss (SBWL) or to a behavioral program that included a SC paradigm. Both groups engaged in social cohesion activities. Participants in SC who did not meet weight goals did not attend group meetings; instead, they received individual treatment with a new interventionist and returned to group once their weight goals were met. SC did not improve overall weight loss outcomes (SC: ?10.0 ± 4.9 kg, SBWL: ?10.8 ± 6.4 kg, P = 0.63). Similarly, overall weight loss was not significantly different in the subgroup of participants in the SC and SBWL conditions who did not meet periodic weight loss goals (?7.3 ± 4.1 kg vs. ?7.1 ± 3.5 kg, P = 0.90). Surprisingly, “successful” SC participants (who met their weight goals) actually lost less weight than “successful” SBWL participants (?12.4 ± 3.2 kg vs. ?14.5 ± 4.7 kg, P = 0.02). Whereas contingency‐based treatments have been tested for other health behaviors (e.g., substance abuse), this is the first study to test a SC intervention for weight loss. This approach did not improve overall weight loss outcomes. Our attempt to offer appropriate clinical care by providing individual treatment to SC participants when needed may have mitigated the effects of the SC paradigm.     

Behavioral transitions and weight change patterns within the PREMIER trial

Little is known about the transition in behaviors from short-term weight loss to maintenance of weight loss. We wanted to determine how short-term and long-term weight loss and patterns of weight change were associated with intervention behavioral targets. This analysis includes overweight/obese participants in active treatment (n = 507) from the previously published PREMIER trial, an 18-month, multicomponent lifestyle intervention for blood pressure reduction, including 33 intervention sessions and recommendations to self-monitor food intake and physical activity daily. Associations between behaviors (attendance, recorded days/week of physical activity, food records/week) and weight loss of ≥5% at 6 and 18 months were examined using logistic regression. We characterized the sample using 5 weight change categories (weight gained, weight stable, weight loss then relapse, late weight loss, and weight loss then maintenance) and analyzed adherence to the behaviors for each category, comparing means with ANOVA. Participants lost an average of 5.3 ± 5.6 kg at 6 months and 4.0 ± 6.7 kg (4.96% of body weight) by 18 months. Higher levels of attendance, food record completion, and recorded days/week of physical activity were associated with increasing odds of achieving 5% weight loss. All weight change groups had declines in the behaviors over time; however, compared to the other four groups, the weight loss/maintenance group (n = 154) had statistically less significant decline in number of food records/week (48%), recorded days/week of physical activity (41.7%), and intervention sessions attended (12.8%) through 18 months. Behaviors associated with short-term weight loss continue to be associated with long-term weight loss, albeit at lower frequencies. Minimizing the decline in these behaviors may be important in achieving long-term weight loss.     

Optimizing healthy gestational weight gain in women at high risk of gestational diabetes: A randomized controlled trial

Objective:

Optimizing gestational weight gain (GWG) in early pregnancy is of clinical and public health importance, especially in higher risk pregnancies.

Design and Methods:

In a robustly designed, randomized controlled trial, 228 pregnant women at risk of developing gestational diabetes mellitus (GDM) were allocated to either control (written health information only) or intervention (four‐session lifestyle program). All women received standard maternal care. Measures were completed at 12‐15 and 26‐28 weeks gestation. Measures included anthropometrics (weight and height), physical activity (pedometer and International Physical Activity Questionnaire), questionnaires (risk perception), and GDM screening.

Results:

The mean (SD) age [31.7 (4.5) and 32.4 (4.7) years] and body mass index [BMI; 30.3 (5.9) and 30.4 (5.6) kg/m²] were similar between control and intervention groups, respectively. By 28 weeks, GWG was significantly different between control and intervention groups [6.9 (3.3) vs. 6.0 (2.8) kg, P < 0.05]. When stratified according to baseline BMI, overweight women in the control group gained significantly more weight compared to overweight women in the intervention group [7.8 (3.4) vs. 6.0 (2.2) kg, P < 0.05], yet in obese women, GWG was similar in both groups. Physical activity levels declined by 28 weeks gestation overall (P < 0.01); however, the intervention group retained a 20% higher step count compared to controls [5,203 (3,368) vs. 4,140 (2,420) steps/day, P < 0.05]. Overall, GDM prevalence was 22%, with a trend toward less cases in the intervention group (P = 0.1).

Conclusions:

Results indicate that a low‐intensity lifestyle intervention, integrated with antenatal care, optimizes healthy GWG and attenuates physical activity decline in early pregnancy. Efficacy in limiting weight gain was greatest in overweight women and in high‐risk ethnically diverse women.