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

Primary Purpose

Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

TOPS

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Duke General Internal Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TOPS

Arm Description

Participants will attend weekly TOPS meetings with standard weekly weigh ins

Outcomes

Primary Outcome Measures

Change in Weight

Weekly weight data will be collected by the DOC Designee at baseline, 12, 24, and 52 weeks.

Secondary Outcome Measures

Program Attendance

Calculate the percentage of TOPS at DOC group session attendance (sessions attended/total offered).

Retention as measured by attendance sheets

Calculate the retention of participants in the TOPS at DOC program at 12, 24, and 52 weeks.

Full Information

NCT ID

NCT03202420

First Posted

June 27, 2017

Last Updated

February 13, 2020

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT03202420

Brief Title

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

Acronym

TOPS at DOC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

December 22, 2017 (Actual)

Primary Completion Date

December 5, 2019 (Actual)

Study Completion Date

December 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TOPS

Arm Type

Experimental

Arm Description

Participants will attend weekly TOPS meetings with standard weekly weigh ins

Intervention Type

Other

Intervention Name(s)

TOPS

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Weight

Description

Weekly weight data will be collected by the DOC Designee at baseline, 12, 24, and 52 weeks.

Time Frame

Baseline, 12, 24, and 52 weeks

Secondary Outcome Measure Information:

Title

Program Attendance

Description

Calculate the percentage of TOPS at DOC group session attendance (sessions attended/total offered).

Time Frame

52 Weeks

Title

Retention as measured by attendance sheets

Description

Calculate the retention of participants in the TOPS at DOC program at 12, 24, and 52 weeks.

Time Frame

12, 24 and 52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nia S Mitchell, MD, MPH

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke General Internal Medicine

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27701

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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