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
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|
|Weight Loss||Behavioral: Weight loss Groups|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Volunteer Peer-Led Intervention for Weight Control in Primary Care|
|Study Start Date :||February 2013|
|Primary Completion Date :||August 2013|
|Study Completion Date :||August 2013|
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.
- 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.
- BMI [ Time Frame: 12 weeks after initial consent ]Change in BMI from baseline to follow up will be assessed using a scale and stadiometer.
- Blood Pressure [ Time Frame: 12 weeks after initial consent ]Blood pressure will be recorded using an OMRON automatic blood pressure cuff.
- Physical Activity [ Time Frame: 12 weeks after initial consent ]Assessed by the International Physical Activity Questionnaire
- Dietary Intake [ Time Frame: 12 weeks after initial consent ]Assessed using the NCI Dietary History Questionnaire
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
|United States, Pennsylvania|
|Penn State College of Medicine, Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Jennifer L Kraschnewski, MD, MPH||Penn State College of Medicine, Penn State Milton S. Hershey Medical Center|