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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: TOPS

• Registration Number: NCT03202420
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-06-27
• Study First Posted: 2017-06-28
• Study Start: 2017-12-22
• Primary Completion: 2019-12-05
• Study Completion: 2019-12-05
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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).

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TOPS	TOPS	Participants will attend weekly TOPS meetings with standard weekly weigh ins

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Duke General Internal Medicine; 🇺🇸 Durham, North Carolina, United States