NCT04639076

Study of a Personalized vs. Standard Approach to Weight Loss Recommendations

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to develop and test the feasibility of a behavioral weight loss intervention that uses personalized recommendations for diet and physical activity behaviors in a behavioral weight loss program and to explore factors associated with treatment adherence and response. The 12-week intervention will utilize digital tools for self-monitoring and counseling by weight management professionals. Exploratory analyses will be conducted to determine if there are genetic, metabolomic, microbiome, or psychosocial factors associated with treatment response.

Detailed description

The primary objective of the study is to test a personalized approach for prescribing weight loss strategies in overweight adults participating in a weight loss intervention and to determine if a personalized approach can optimize weight loss compared to a standard behavioral weight loss intervention. Thus, all participants will receive a behavioral weight loss intervention delivered via remote counseling and digital tools including a smart phone app, Wi-Fi- enabled smart scale, physical activity tracker. Participants in the personalized group will also use a continuous blood glucose monitoring (CGM) device. The differences between the two groups will be the approach used to recommend diet and physical activity changes. The study will compare a Standard Behavioral Weight Loss (BWL) approach tested in numerous previous studies and consistent with current clinical practice, to a Personalized Behavioral Weight Loss (PBWL) approach that tests a combination of diet and physical activity prescriptions to determine the best "fit" for the participant. The PWBL group will actively use CGM information during the intervention period to inform diet and activity behaviors. Participants will be randomized in a 3:1 ratio to PBWL or BWL (i.e., 30 to PBWL and 10 to BWL). 1. Behavioral Weight Loss: The BWL group will receive a standard weight loss intervention based on the evidence-based interventions currently being recommended for clinical practice, with general recommendations for caloric reductions based on starting weight and aimed at achieving a 1-2 lb. average weekly weight loss, and progressive weekly increases of physical activity. Supporting behavioral lessons adapted from materials used in the Diabetes Prevention Program, a landmark behavioral weight loss intervention, will also be delivered. The weight loss 'prescription' will remain consistent throughout the 3 month trial. 2. Personalized Behavioral Weight Loss: The PBWL group will receive a weight loss intervention that is personalized for diet and physical activity recommendations based on a testing period where various approaches to eating and physical activity that may result in differential adherence and response are tested. Calorie recommendations will be based on measured resting energy expenditure and expected activity levels and aimed at achieving a 1-2 lb. average weekly weight loss. In the initial weeks, participants will test various diet and physical activity prescriptions. Following this period, the optimal combination will be identified by the participant, in consultation with their interventionist, based on measured blood glucose, weight loss, hunger and ability to adhere to the prescription. Diet composition (percentage of calories from fat, carbohydrates, and protein) will be personalized along with meal frequency and physical activity goals. This group will receive the same supporting behavioral lessons as the BWL group along with additional resources specific to their personalized prescription. The weight loss 'prescription' will vary across the 3-month trial based on response to treatment.

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral Weight Loss Program	The BWL group will receive a standard weight loss intervention based on the evidence-based interventions currently being recommended for clinical practice, with general recommendations for caloric reductions based on starting weight and progressive weekly increases of physical activity (PA). Supporting behavioral lessons based on materials used in the Diabetes Prevention Program (DPP) will also be delivered. The weight loss 'prescription' will remain consistent throughout the 3 month trial. Participants will receive digital tools including a study smart phone app that incorporates diet self-monitoring, tracking of behavioral goals, behavioral lessons and resources, and integration of data from a study-provided Wi-Fi enabled scale and physical activity tracker.
BEHAVIORAL	Personalized Behavioral Weight Loss Program	The PBWL group will receive a calorie goal based on measured resting energy expenditure and baseline PA. In Weeks 1-4, participants will be randomly assigned to test patterns that manipulate diet composition (low-fat or low-carbohydrate), meal frequency (3 or 5-6 meals/day), and PA goals (weekly minutes or daily minutes goals). Following this period, the optimal combination will be identified by the participant and interventionist, based on weight loss, blood glucose, hunger and ability to adhere to the prescription. This group will receive the same supporting behavioral lessons as the BWL group along with additional resources specific to their personalized prescription. The weight loss 'prescription' will vary across the 3-month trial based on response to treatment. Participants will receive the same digital tools as the BWL group with resources specific to following the prescription they are following during any given program week.

Timeline

• Start date: 2020-10-21
• Primary completion: 2021-05-10
• Completion: 2021-05-10
• First posted: 2020-11-20
• Last updated: 2021-10-07

Locations

1 site across 1 country: United States