Mediators of weight change in underserved patients with obesity: exploratory analyses from the Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL) cluster-randomized trial.

BACKGROUND: Intensive lifestyle interventions (ILIs) stimulate weight loss in underserved patients with obesity, but the mediators of weight change are unknown. OBJECTIVES: We aimed to identify the mediators of weight change during an ILI compared with usual care (UC) in underserved patients with obesity. METHODS: The PROPEL (Promoting Successful Weight Loss in Primary Care in Louisiana) trial randomly assigned 18 clinics (n = 803) to either an ILI or UC for 24 mo. The ILI group received an intensive lifestyle program; the UC group had routine care. Body weight was measured; further, eating behaviors (restraint, disinhibition), dietary intake (percentage fat intake, fruit and vegetable intake), physical activity, and weight- and health-related quality of life constructs were measured through questionnaires. Mediation analyses assessed whether questionnaire variables explained between-group variations in weight change during 2 periods: baseline to month 12 (n = 779) and month 12 to month 24 (n = 767). RESULTS: The ILI induced greater weight loss at month 12 compared with UC (between-group difference: -7.19 kg; 95% CI: -8.43, -6.07 kg). Improvements in disinhibition (-0.33 kg; 95% CI: -0.55, -0.10 kg), percentage fat intake (-0.25 kg; 95% CI: -0.50, -0.01 kg), physical activity (-0.26 kg; 95% CI: -0.41, -0.09 kg), and subjective fatigue (-0.28 kg; 95% CI: -0.46, -0.10 kg) at month 6 during the ILI partially explained this between-group difference. Greater weight loss occurred in the ILI at month 24, yet the ILI group gained 2.24 kg (95% CI: 1.32, 3.26 kg) compared with UC from month 12 to month 24. Change in fruit and vegetable intake (0.13 kg; 95% CI: 0.05, 0.21 kg) partially explained this response, and no variables attenuated the weight regain of the ILI group. CONCLUSIONS: In an underserved sample, weight change induced by an ILI compared with UC was mediated by several psychological and behavioral variables. These findings could help refine weight management regimens in underserved patients with obesity.This trial was registered at clinicaltrials.gov as NCT02561221.

Weight Loss in Underserved Patients - A Cluster-Randomized Trial.

BACKGROUND: Evidence of the effectiveness of treatment for obesity delivered in primary care settings in underserved populations is lacking. METHODS: We conducted a cluster-randomized trial to test the effectiveness of a high-intensity, lifestyle-based program for obesity treatment delivered in primary care clinics in which a high percentage of the patients were from low-income populations. We randomly assigned 18 clinics to provide patients with either an intensive lifestyle intervention, which focused on reduced caloric intake and increased physical activity, or usual care. Patients in the intensive-lifestyle group participated in a high-intensity program delivered by health coaches embedded in the clinics. The program consisted of weekly sessions for the first 6 months, followed by monthly sessions for the remaining 18 months. Patients in the usual-care group received standard care from their primary care team. The primary outcome was the percent change from baseline in body weight at 24 months. RESULTS: All 18 clinics (9 assigned to the intensive program and 9 assigned to usual care) completed 24 months of participation; a median of 40.5 patients were enrolled at each clinic. A total of 803 adults with obesity were enrolled: 452 were assigned to the intensive-lifestyle group, and 351 were assigned to the usual-care group; 67.2% of the patients were Black, and 65.5% had an annual household income of less than $40,000. Of the enrolled patients, 83.4% completed the 24-month trial. The percent weight loss at 24 months was significantly greater in the intensive-lifestyle group (change in body weight, -4.99%; 95% confidence interval [CI], -6.02 to -3.96) than in the usual-care group (-0.48%; 95% CI, -1.57 to 0.61), with a mean between-group difference of -4.51 percentage points (95% CI, -5.93 to -3.10) (P<0.001). There were no significant between-group differences in serious adverse events. CONCLUSIONS: A high-intensity, lifestyle-based treatment program for obesity delivered in an underserved primary care population resulted in clinically significant weight loss at 24 months. (Funded by the Patient-Centered Outcomes Research Institute and others; PROPEL ClinicalTrials.gov number, NCT02561221.).

Association between breakfast frequency and physical activity and sedentary time: a cross-sectional study in children from 12 countries.

BACKGROUND: Existing research has documented inconsistent findings for the associations among breakfast frequency, physical activity (PA), and sedentary time in children. The primary aim of this study was to examine the associations among breakfast frequency and objectively-measured PA and sedentary time in a sample of children from 12 countries representing a wide range of human development, economic development and inequality. The secondary aim was to examine interactions of these associations between study sites. METHODS: This multinational, cross-sectional study included 6228 children aged 9-11 years from the 12 International Study of Childhood Obesity, Lifestyle and the Environment sites. Multilevel statistical models were used to examine associations between self-reported habitual breakfast frequency defined using three categories (breakfast consumed 0 to 2 days/week [rare], 3 to 5 days/week [occasional] or 6 to 7 days/week [frequent]) or two categories (breakfast consumed less than daily or daily) and accelerometry-derived PA and sedentary time during the morning (wake time to 1200 h) and afternoon (1200 h to bed time) with study site included as an interaction term. Model covariates included age, sex, highest parental education, body mass index z-score, and accelerometer waking wear time. RESULTS: Participants averaged 60 (s.d. 25) min/day in moderate-to-vigorous PA (MVPA), 315 (s.d. 53) min/day in light PA and 513 (s.d. 69) min/day sedentary. Controlling for covariates, breakfast frequency was not significantly associated with total daily or afternoon PA and sedentary time. For the morning, frequent breakfast consumption was associated with a higher proportion of time in MVPA (0.3%), higher proportion of time in light PA (1.0%) and lower min/day and proportion of time sedentary (3.4 min/day and 1.3%) than rare breakfast consumption (all p ≤ 0.05). No significant associations were found when comparing occasional with rare or frequent breakfast consumption, or daily with less than daily breakfast consumption. Very few significant interactions with study site were found. CONCLUSIONS: In this multinational sample of children, frequent breakfast consumption was associated with higher MVPA and light PA time and lower sedentary time in the morning when compared with rare breakfast consumption, although the small magnitude of the associations may lack clinical relevance. TRIAL REGISTRATION: The International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE) is registered at (Identifier NCT01722500 ).