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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: TOPS

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Duke General Internal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants must be patients of the DOC.
• BMI: Asian patients with a BMI of ≥23 kg/m2 and patients of other racial and ethnic backgrounds will be included if have a BMI of ≥25 kg/m2. Asian patients are allowed to participate at a BMI in the normal range because they are more likely to develop diabetes (or insulin resistance or glucose intolerance at a BMI of 23 kg/m2).

Exclusion Criteria:

• Mental illness that would cause disruptions to group meetings
• Cognitive impairment that would preclude participants from understanding the program
• Type 2 diabetics on insulin or sulfonylureas without provider approval
• untreated hyper- or hypothyroidism
• current cancer diagnosis
• history of cancer (other than skin cancer)
• gastrointestinal disorders affecting food intake
• use of medications thought to effect metabolism, body weight, energy expenditure, or appetite
• women currently pregnant or lactating, planning to become pregnant, or less than 6 months post-partum
• weight loss of > 5% in past 6 months
• major psychiatric disorder
• current moderate to severe symptoms of depression
• eating disorders
• current alcohol or substance abuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TOPS; Participants will attend weekly TOPS meetings with standard weekly weigh ins	Other: TOPS; Take Off Pounds Sensibly (TOPS) is a national, nonprofit, peer-led, group-based, weight loss program that offers a comprehensive program on diet and physical activity with group support for weight management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weight	Weekly weight data will be collected by the DOC Designee at baseline, 12, 24, and 52 weeks.	Baseline, 12, 24, and 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Program Attendance	Calculate the percentage of TOPS at DOC group session attendance (sessions attended/total offered).	52 Weeks
Retention as measured by attendance sheets	Calculate the retention of participants in the TOPS at DOC program at 12, 24, and 52 weeks.	12, 24 and 52 weeks

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Nia S Mitchell, MD, MPH, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2017
• Primary Completion (Actual): December 5, 2019
• Study Completion (Actual): December 5, 2019

Study Registration Dates

• First Submitted: June 27, 2017
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes
• Other Study ID Numbers: Pro00080518

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No