Impact of Volunteer Peer-Led Intervention for Weight Control in Primary Care (KL2)

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss
• Intervention / Treatment: Behavioral: Weight loss Groups

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

PEER 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

Participant Inclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: 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.
EXPERIMENTAL: Weight Loss Groups; Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Weight	We will assess our participants to evaluate the percent change in weight over the 12 week period of the study using a scale.	12 weeks after initial consent

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	Change in BMI from baseline to follow up will be assessed using a scale and stadiometer.	12 weeks after initial consent
Blood Pressure	Blood pressure will be recorded using an OMRON automatic blood pressure cuff.	12 weeks after initial consent
Physical Activity	Assessed by the International Physical Activity Questionnaire	12 weeks after initial consent
Dietary Intake	Assessed using the NCI Dietary History Questionnaire	12 weeks after initial consent

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: April 29, 2013
• First Submitted That Met QC Criteria: May 7, 2013
• First Posted (ESTIMATE): May 9, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): June 11, 2015
• Last Update Submitted That Met QC Criteria: May 27, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Weight loss
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: KL2; UL1TR000127 (NIH); KL2TR000126 (NIH)