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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR000127 | U.S. NIH Grant/Contract | View source | |
| KL2TR000126 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 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 | Experimental | Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks after initial consent |
| Measure | Description | Time Frame |
|---|---|---|
| BMI | Change in BMI from baseline to follow up will be assessed using a scale and stadiometer. | 12 weeks after initial consent |
| Blood Pressure | Blood pressure will be recorded using an OMRON automatic blood pressure cuff. |
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PEER Inclusion Criteria:
Participant Inclusion Criteria:
Exclusion Criteria:
Current or planned pregnancy within the next year
Medical or other contraindications to weight loss, including, but not limited to, history of:
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)
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer L Kraschnewski, MD, MPH | Penn State College of Medicine, Penn State Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State College of Medicine, Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Full Range | percent weight change | 12 weeks after initial consent |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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This was a pilot study. No other limitations noted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Kraschnewski | Penn State Hershey Medical Center | 717-531-8161 | jkraschnewski@hmc.psu.edu |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 12 weeks after initial consent |
| Physical Activity | Assessed by the International Physical Activity Questionnaire | 12 weeks after initial consent |
| Dietary Intake | Assessed using the NCI Dietary History Questionnaire | 12 weeks after initial consent |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | BMI | Change in BMI from baseline to follow up will be assessed using a scale and stadiometer. | Posted | Mean | Full Range | kg/m^2 | 12 weeks after initial consent |
|
|
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| Secondary | Blood Pressure | Blood pressure will be recorded using an OMRON automatic blood pressure cuff. | Not Posted | 12 weeks after initial consent |
| Secondary | Physical Activity | Assessed by the International Physical Activity Questionnaire | Not Posted | 12 weeks after initial consent |
| Secondary | Dietary Intake | Assessed using the NCI Dietary History Questionnaire | Not Posted | 12 weeks after initial consent |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | 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. | 0 | 40 | 0 | 40 |
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