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

Weight Loss Clinical Trial

— KL2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850550
• Other study ID #: KL2
• Secondary ID: UL1TR000127KL2TR
• Status: Completed
• Phase: N/A
• First received: April 29, 2013
• Last updated: May 27, 2015
• Start date: February 2013
• Est. completion date: August 2013

Study information

• Verified date: May 2015
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
United States	Penn State College of Medicine, Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	BMI	Change in BMI from baseline to follow up will be assessed using a scale and stadiometer.	12 weeks after initial consent	No
Secondary	Blood Pressure	Blood pressure will be recorded using an OMRON automatic blood pressure cuff.	12 weeks after initial consent	No
Secondary	Physical Activity	Assessed by the International Physical Activity Questionnaire	12 weeks after initial consent	No
Secondary	Dietary Intake	Assessed using the NCI Dietary History Questionnaire	12 weeks after initial consent	No