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

Abstract

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.

Keywords: Dietary intervention; Energy expenditure; Feeding protocol; Obesity; Research partnership; Weight-loss maintenance.

Copyright © 2017 Elsevier Inc. All rights reserved.

Figures

Figure 1

Study Design

Figure 2

Flow Diagram

Figure 3. Statistical Power

Power of one-way ANOVA to detect deviation of mean ΔTEE under one diet from the other two (inset). Each curve represents a fixed sample size. Dot indicates detectable effect, 237 kcal/d at 80% power, with proposed 45/arm. Curves based on non-central F distribution, 5% Type I error, between-subject standard deviation 412 kcal/d as in preliminary data.