Impact of Volunteer Peer-Led Intervention for Weight Control in Primary Care

NCT ID: NCT01850550

Last Updated: 2015-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-08-31

Brief Summary

The specific objective of this research proposal is to determine the short-term efficacy of a primary care-based weight control intervention in which successful volunteer peers deliver a group-based program.

The purpose of the study is to conduct a pilot randomized controlled trial (RCT) of a successful volunteer peer-led weight control program compared to a control condition to determine intervention efficacy at 3 months. Six peer leaders from 2 primary care clinics will be recruited and trained to conduct the intervention. Overweight and obese patients (n=80) will be recruited (randomized by individual) to determine weight loss at 3 months (primary outcome). The program consists of 12 weekly weight loss sessions led by a successful volunteer peer leader using an adaptation of the Diabetes Prevention Program to help participants lose weight.

Detailed Description

The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. The initial weight loss session will be conducted by the peer leaders with oversight by the PI. This session will serve to introduce the program and give an overview of program. The remaining sessions, conducted by co-peer leaders, will utilize an adaptation of the Diabetes Prevention Program. This adaptation allows for use in a group setting and facilitation by a lay individual.

Control Condition: Participants in the control condition will be given written information at the baseline visit from the NIH website "Aim for a Healthy Weight" to provide a basic understanding of weight loss and access to basic online resources. We expect that use of the website may result in some weight loss. However, similar information-only interventions have had a very small effect, which is accounted for in the sample size calculation.

Conditions

Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

Participants in the control condition will be given written information at the baseline visit from the NIH website "Aim for a Healthy Weight" to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Weight Loss Groups

Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.

Group Type: EXPERIMENTAL

Weight loss Groups

Intervention Type: BEHAVIORAL

The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions.

Interventions

Weight loss Groups

The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Successful at volitional weight loss, defined as at least 10% of their initial body weight and maintenance for ≥ 1 year
• Fluently speak and read English
• Willing to volunteer 1 hour each week as a group leader
• Able and willing to give informed consent.
• Must have internet access

• Fluently speak and read English
• Able and willing to give informed consent
• Body Mass Index > 25 and < 45
• Interested in participating in weekly group sessions for weight loss
• Must have internet access

Exclusion Criteria

• Current or planned pregnancy within the next year
• Medical or other contraindications to weight loss, including, but not limited to, history of:

1. Myocardial infarction

2. Stroke

3. Unstable angina

4. Congestive heart failure

5. Cancer (except non-melanoma skin cancer)

• History of gastric bypass surgery or scheduled surgery for this purpose
• Current use of prescription medication for weight loss
• Weight loss of > 5% of current body weight in previous 6 months
• Contraindications to weight loss
• Evidence of severe cognitive impairment or major psychiatric illness
• Plans to move in the next 6 months
• Answering yes to any question on the Physical Activity Readiness Questionnaire (PAR-Q)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Kraschnewski

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer L Kraschnewski, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Locations

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

UL1TR000127

Identifier Type: NIH

Identifier Source: secondary_id

View Link

KL2TR000126

Identifier Type: NIH

Identifier Source: secondary_id

View Link

KL2

Identifier Type: -

Identifier Source: org_study_id