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

Primary Purpose

Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight loss Groups
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weight Loss focused on measuring Weight loss

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Weight Loss Groups

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

BMI
Change in BMI from baseline to follow up will be assessed using a scale and stadiometer.
Blood Pressure
Blood pressure will be recorded using an OMRON automatic blood pressure cuff.
Physical Activity
Assessed by the International Physical Activity Questionnaire
Dietary Intake
Assessed using the NCI Dietary History Questionnaire

Full Information

First Posted
April 29, 2013
Last Updated
May 27, 2015
Sponsor
Milton S. Hershey Medical Center
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01850550
Brief Title
Impact of Volunteer Peer-Led Intervention for Weight Control in Primary Care
Acronym
KL2
Official Title
Impact of Volunteer Peer-Led Intervention for Weight Control in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
Keywords
Weight loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Weight Loss Groups
Arm Type
Experimental
Arm Description
Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.
Intervention Type
Behavioral
Intervention Name(s)
Weight loss Groups
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent Change in Weight
Description
We will assess our participants to evaluate the percent change in weight over the 12 week period of the study using a scale.
Time Frame
12 weeks after initial consent
Secondary Outcome Measure Information:
Title
BMI
Description
Change in BMI from baseline to follow up will be assessed using a scale and stadiometer.
Time Frame
12 weeks after initial consent
Title
Blood Pressure
Description
Blood pressure will be recorded using an OMRON automatic blood pressure cuff.
Time Frame
12 weeks after initial consent
Title
Physical Activity
Description
Assessed by the International Physical Activity Questionnaire
Time Frame
12 weeks after initial consent
Title
Dietary Intake
Description
Assessed using the NCI Dietary History Questionnaire
Time Frame
12 weeks after initial consent

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer L Kraschnewski, MD, MPH
Organizational Affiliation
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

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

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