An Academia-Industry Partnership for Planning and Executing a Community-Based Feeding Study.

A research team from Boston Children's Hospital and Harvard Medical School conducted a community-based feeding study in collaboration with Framingham State University (FSU) and Sodexo, the food service contractor at FSU. The study was a randomized controlled trial, implemented on the FSU campus. For the final year of the study, a satellite feeding site was established at Assabet Valley Regional Technical High School. The purpose of the study was to assess the biological effects of different macronutrient diets. An academia-industry partnership was developed to overcome common challenges associated with hospital-based feeding studies. Benefits included the following: a study site outside of Boston (reducing inconvenience for participants), access to a large commercial kitchen and study-specific kiosk (promoting efficiency), collaboration with Sodexo chefs (ensuring palatability of meals), and opportunity to procure food from contracted vendors. The research (academia) and food service (industry) teams worked together to design, plan, and execute intervention protocols using an integrated approach. During execution, the research team was primarily responsible for overseeing treatment fidelity, whereas the food service team provided culinary expertise, with a strong focus on hospitality and food quality. The study was conducted in 3 cohorts between August 2014 and May 2017. Participants received all of their food for ∼30 wk, totaling >160,000 meals. For all 3 cohorts combined, 234 participants provided informed consent, 229 started a standard run-in weight-loss diet, 164 lost a mean ± SD 12% ± 2% of baseline body weight and were randomly assigned to different macronutrient diets for weight-loss maintenance, and 148 completed the study. During the final and largest cohort, as many as 114 participants received daily meals concurrently. The daily cost per participant for preparation and service of weighed meals and snacks was ∼$65. This academia-industry partnership provides a model for controlled feeding protocols in nutrition research, potentially with enhanced cost-effectiveness, practicality, and generalizability. This trial was registered at http://www.clinicaltrials.gov as NCT02068885.

A randomized study of dietary composition during weight-loss maintenance: Rationale, study design, intervention, and assessment.

BACKGROUND: While many people with overweight or obesity can lose weight temporarily, most have difficulty maintaining weight loss over the long term. Studies of dietary composition typically focus on weight loss, rather than weight-loss maintenance, and rely on nutrition education and dietary counseling, rather than controlled feeding protocols. Variation in initial weight loss and insufficient differentiation among treatments confound interpretation of results and compromise conclusions regarding the weight-independent effects of dietary composition. The aim of the present study was to evaluate three test diets differing in carbohydrate-to-fat ratio during weight-loss maintenance. DESIGN AND DIETARY INTERVENTIONS: Following weight loss corresponding to 12±2% of baseline body weight on a standard run-in diet, 164 participants aged 18 to 65years were randomly assigned to one of three test diets for weight-loss maintenance through 20weeks (test phase). We fed them high-carbohydrate (60% of energy from carbohydrate, 20% fat), moderate-carbohydrate (40% carbohydrate, 40% fat), and low-carbohydrate (20% carbohydrate, 60% fat) diets, controlled for protein content (20% of energy). During a 2-week ad libitum feeding phase following the test phase, we assessed the effect of the test diets on body weight. OUTCOMES: The primary outcome was total energy expenditure, assessed by doubly-labeled water methodology. Secondary outcomes included resting energy expenditure and physical activity, chronic disease risk factors, and variables to inform an understanding of physiological mechanisms by which dietary carbohydrate-to-fat ratio might influence metabolism. Weight change during the ad libitum feeding phase was conceptualized as a proxy measure of hunger.

Influences of prior miscarriage and weight status on perinatal psychological well-being, exercise motivation and behavior.

OBJECTIVES: women who have experienced miscarriage may be at increased risk for elevated depressive and anxiety symptoms in subsequent pregnancies. Exercise may be a useful strategy for coping with these symptoms. Little is known about how miscarriage influences prenatal exercise behavior. The study purpose was to examine the influences of miscarriage history and prepregnancy weight status on pregnant women's psychological health, exercise motivation, and behavior using the Theory of Planned Behavior. PARTICIPANTS/SETTING: Pregnant women (N=203; 41 with prior miscarriage; 72 overweight/obese; BMI > 25.0) in the northeast United States. DESIGN: Women prospectively reported their depressive/anxiety symptoms and exercise motivation/behavior in the 1st, 2nd, and 3rd trimesters via mailed surveys. Group differences in depressive/anxiety symptoms, exercise behavior, and its motivational determinants were examined using Chi Square analyses and Univariate and Multivariate Analyses of Covariance. MEASUREMENTS AND FINDINGS: Women with a history of miscarriage had higher 1st and 2nd trimester depressive/anxiety symptoms and lower 1st trimester attitudes about exercise and 1st and 2nd trimester perceived behavior control than women without a history of miscarriage. Overweight/obese women had higher 1st and 2nd trimester pregnancy depressive/anxiety symptoms, engaged in less prepregnancy exercise, and had lower levels of exercise intention, attitude, and perceived behavior control throughout pregnancy than normal weight women. KEY CONCLUSIONS: Women with a history of miscarriage and overweight/obese women have poorer psychological health and lower motivation to exercise during pregnancy than women without a history of miscarriage and normal weight women. IMPLICATIONS FOR PRACTITIONERS: Interventions and healthcare provider communications aimed at promoting perinatal exercise behavior and psychological health should take into account pre-pregnancy weight status and pregnancy history to identify strategies to help women, particularly overweight/obese women with a history of miscarriage, to overcome exercise barriers.

The Power of Believing: Salient Belief Predictors of Exercise Behavior in Normal Weight, Overweight, and Obese Pregnant Women.

BACKGROUND: Nearly 50% of U.S. women enter pregnancy as overweight or obese (OW/OB). There is a critical need to understand how to motivate OW/OB pregnant women for exercise behavior to improve their health and reduce adverse pregnancy outcomes. PURPOSE: To examine salient Theory of Planned Behavior belief predictors of normal weight (NW) and OW/OB pregnant women's exercise behavior (EXB) across pregnancy. METHODS: Pregnant women (N = 357) self-reported their exercise beliefs and behavior during each pregnancy trimester. Pearson correlations were used to examine exercise beliefs-behavior associations. Stepwise regressions were used to identify trimester (TRI) 1 and TRI 2 belief predictors of TRI 2 and TRI 3 EXB, respectively, for each weight status group. Belief endorsement was examined to identify critical beliefs. RESULTS: TRI 1 EXB beliefs explained 58% of the total variance (22% NW, 36% OW/OB) in TRI 2 EXB. TRI 2 EXB beliefs explained 32% of the total variance (17% NW, 15% OW/OB) in TRI 3 EXB. Individual beliefs varied by weight status and trimester. Control beliefs emerged with the lowest endorsement; making them most critical to target for exercise interventions. CONCLUSION: Prenatal exercise interventions should be weight status specific and target salient beliefs/barriers unique to the pregnancy trimesters.