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

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ClinicalTrials.gov Identifier: NCT01850550
Recruitment Status : Completed
First Posted : May 9, 2013
Results First Posted : June 11, 2015
Last Update Posted : June 11, 2015
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jennifer Kraschnewski, Milton S. Hershey Medical Center

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.


Condition or disease Intervention/treatment Phase
Weight Loss Behavioral: Weight loss Groups Not Applicable

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  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Volunteer Peer-Led Intervention for Weight Control in Primary Care
Study Start Date : February 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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:

    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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850550


Locations
United States, Pennsylvania
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
National Institutes of Health (NIH)
Investigators
Principal Investigator: Jennifer L Kraschnewski, MD, MPH Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Responsible Party: Jennifer Kraschnewski, Assistant Professor of Medicine, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01850550     History of Changes
Other Study ID Numbers: KL2
UL1TR000127 ( U.S. NIH Grant/Contract )
KL2TR000126 ( U.S. NIH Grant/Contract )
First Posted: May 9, 2013    Key Record Dates
Results First Posted: June 11, 2015
Last Update Posted: June 11, 2015
Last Verified: May 2015

Keywords provided by Jennifer Kraschnewski, Milton S. Hershey Medical Center:
Weight loss

Additional relevant MeSH terms:
Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes