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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01850550

Acronym

KL2

Enrollment

Registered

2013-05-09

Start date

2013-02-28

Completion date

2013-08-31

Last updated

2015-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight Loss

Keywords

Weight loss

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.

Interventions

BEHAVIORALWeight 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 65 Years

Healthy volunteers

Yes

Inclusion 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)

Design outcomes

Primary

Measure	Time frame	Description
Percent Change in Weight	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

Measure	Time frame	Description
BMI	12 weeks after initial consent	Change in BMI from baseline to follow up will be assessed using a scale and stadiometer.
Blood Pressure	12 weeks after initial consent	Blood pressure will be recorded using an OMRON automatic blood pressure cuff.
Physical Activity	12 weeks after initial consent	Assessed by the International Physical Activity Questionnaire
Dietary Intake	12 weeks after initial consent	Assessed using the NCI Dietary History Questionnaire

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	40
Weight Loss Groups Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program. 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.	40
Total	80

Baseline characteristics

Characteristic	Control	Weight Loss Groups	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	40 Participants	40 Participants	80 Participants
Region of Enrollment United States	40 participants	40 participants	80 participants
Sex: Female, Male Female	40 Participants	40 Participants	80 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 40	0 / 40
serious Total, serious adverse events	0 / 40	0 / 40

Outcome results

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.