Study to Test the Feasibility, Acceptability, and Weight Change of Take Off Pounds Sensibly (TOPS) in a Safety Net Clinic — TOPS at DOC  

Obesity Clinical Trial

Official title: Pilot Study to Test the Feasibility, Acceptability, and Weight Change of Take Off Pounds Sensibly (TOPS) in a Safety Net Clinic

Status Completed

Clinical Trial Summary

The purpose of this pilot proposal are the following: 1) to determine the feasibility and acceptability of integrating the TOPS weight loss program into underserved populations through an urban safety net clinic and 2) to gather preliminary data of weight change to inform the design of a future randomized, controlled trial to determine the efficacy of the TOPS program in safety net clinics.

To achieve these goals, the investigators will pursue the following Specific Aims:

Specific Aim 1. Assess the feasibility and acceptability of integrating the TOPS program into an urban safety net clinic, with process measures (i.e., recruitment/refusal rates and retention/dropout rates) and focus groups.

Hypothesis 1. Integrating the TOPS program into an urban safety net clinic is feasible and acceptable to participants.

Specific Aim 2. Assess the percent of participants in the TOPS intervention arm with clinically significant weight change (i.e., weight loss of ≥5% of initial body weight) at 12, 26, and 52 weeks.

Hypothesis 2. 10%, 25%, and 33% of participants in the TOPS intervention arm will lose ≥5% of initial body weight at 12, 26, and 52 weeks, respectively.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Body Weight Changes
• Obesity

• NCT number: NCT03202420
• Study type: Interventional
• Source: Duke University
• Status: Completed
• Phase: N/A
• Start date: December 22, 2017
• Completion date: December 5, 2019