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

NCT01850550 | Completed Results

• 3 other identifiers: KL2UL1TR000127KL2TR000126
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss

Keywords

Weight loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• BMI

  12 weeks after initial consent

• Blood Pressure

  12 weeks after initial consent

• Physical Activity

  12 weeks after initial consent

• Dietary Intake

  12 weeks after initial consent

Study Arms (2)

Control

NO INTERVENTION

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.

Weight Loss Groups

EXPERIMENTAL

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

Behavioral: Weight loss Groups

Interventions

Weight loss Groups 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.

Weight Loss Groups

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current or planned pregnancy within the next year
• Medical or other contraindications to weight loss, including, but not limited to, history of:
• Myocardial infarction
• Stroke
• Unstable angina
• Congestive heart failure
• 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)

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

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

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This was a pilot study. No other limitations noted.

Results Point of Contact

• Title: Jennifer Kraschnewski
• Organization: Penn State Hershey Medical Center

jkraschnewski@hmc.psu.edu

717-531-8161

Study Officials

• Jennifer L Kraschnewski, MD, MPH

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 9, 2013
• Study Start: February 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 11, 2015
• Results First Posted: June 11, 2015

Record last verified: 2015-05

Locations

US (1)