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Completed

NCT Number: NCT01850550

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

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.

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Key information

Conditions

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

Age range

21 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Percent Change in Weight

    Time frame: 12 weeks after initial consent

    We will assess our participants to evaluate the percent change in weight over the 12 week period of the study using a scale.

Secondary outcomes

  1. BMI

    Time frame: 12 weeks after initial consent

    Change in BMI from baseline to follow up will be assessed using a scale and stadiometer.

  2. Blood Pressure

    Time frame: 12 weeks after initial consent

    Blood pressure will be recorded using an OMRON automatic blood pressure cuff.

  3. Physical Activity

    Time frame: 12 weeks after initial consent

    Assessed by the International Physical Activity Questionnaire

  4. Dietary Intake

    Time frame: 12 weeks after initial consent

    Assessed using the NCI Dietary History Questionnaire

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Acronym: KL2

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 9, 2013
Registry last updated
Jun 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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