Trial Outcomes & Findings for Impact of Volunteer Peer-Led Intervention for Weight Control in Primary Care (NCT NCT01850550)
NCT ID: NCT01850550
Last Updated: 2015-06-11
Results Overview
We will assess our participants to evaluate the percent change in weight over the 12 week period of the study using a scale.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
12 weeks after initial consent
Results posted on
2015-06-11
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Volunteer Peer-Led Intervention for Weight Control in Primary Care
Baseline characteristics by cohort
| Measure |
Control
n=40 Participants
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.
|
Weight Loss Groups
n=40 Participants
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.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after initial consentWe will assess our participants to evaluate the percent change in weight over the 12 week period of the study using a scale.
Outcome measures
| Measure |
Control
n=40 Participants
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.
|
Weight Loss Groups
n=37 Participants
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.
|
|---|---|---|
|
Percent Change in Weight
|
-1.27 percent weight change
Interval -16.8 to 3.99
|
-2.76 percent weight change
Interval -10.37 to 4.01
|
SECONDARY outcome
Timeframe: 12 weeks after initial consentChange in BMI from baseline to follow up will be assessed using a scale and stadiometer.
Outcome measures
| Measure |
Control
n=40 Participants
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.
|
Weight Loss Groups
n=37 Participants
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.
|
|---|---|---|
|
BMI
|
-0.04 kg/m^2
Interval -3.02 to 1.5
|
-0.11 kg/m^2
Interval -4.03 to 1.33
|
SECONDARY outcome
Timeframe: 12 weeks after initial consentBlood pressure will be recorded using an OMRON automatic blood pressure cuff.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeks after initial consentAssessed by the International Physical Activity Questionnaire
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeks after initial consentAssessed using the NCI Dietary History Questionnaire
Outcome measures
Outcome data not reported
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Weight Loss Groups
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jennifer Kraschnewski
Penn State Hershey Medical Center
Phone: 717-531-8161
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place