ObesityPALNCT03163264
The Peer Assisted Lifestyle Intervention
A study testing Peer Assisted Lifestyle in people with Obesity and Overweight, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The PAL intervention uses a new software tool delivered on tablets to facilitate 5As-based weight management counseling with a peer health coach and the VA PACT healthcare team to promote goal-setting, behavior change, and weight loss in the primary care (PC) setting. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Peer Assisted Lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-69 (this age range represents MOVE! eligibility)
- BMI of 30kg/m2 or a BMI of 25kg/m2 with obesity-associated condition
- Under the care of PCP with at least 1 prior visit with the provider in the past 24 months
- Access to a telephone
- Able to travel to Brooklyn VA for in-person evaluations at baseline, 6, and 12 months
Who cannot join
- Non-Veterans
- A documented current history of active psychosis, active bipolar disorder, or other cognitive issues via ICD-10 codes
- Undergoing insulin-therapy for diabetes
- Self-reported inability to read at a 5th grade level due to literacy level or vision problems
- Has attended more than 4 MOVE! sessions in the past year
- Pregnancy
- PCP stating that Veteran should not participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010
About this study
Official title: Testing the Efficacy of a Technology-assisted Intervention to Improve Weight Management of Obese Patients Within Patient Aligned Care Teams at the VA
The PAL intervention uses a new software tool delivered on tablets to facilitate 5As-based weight management counseling with a peer health coach and the VA PACT healthcare team to promote goal-setting, behavior change, and weight loss in the primary care (PC) setting. The PAL intervention also includes 10-12 health-coaching calls to the patient over 12 months.
As part of a cluster-randomized controlled study, the investigators will randomize 17 primary care providers at the Brooklyn VA to receive either the PAL Intervention or an Enhanced Usual Care control. The primary aim of the study is to explore differences in feasibility, acceptability, and intermediate, behavioral, and weight loss outcomes at 6 and 12 months of 520 patients recruited from the randomized primary care providers.
Read more
Objective:
- Explore the feasibility and impact of this intervention on intermediate, behavioral, and weight loss outcomes at 6 and 12 months post-intervention when compared to enhanced usual care.
Read the detailed description
Veterans shoulder a disproportionate burden of obesity and its co-morbidities, including diabetes, hypertension, and hyperlipidemia. Modest weight loss in obese patients through diet and exercise improves health and prevents chronic disease, but primary care providers (PCPs) often fail to adequately counsel patients about their weight due to lack of time and training. Thus, tools and brief interventions are needed to support providers' behavior change counseling. The VA currently offers the MOVE! program to treat overweight and obese patients, but only 9% of eligible patients attend. At the same time, Veterans on average see their PCPs 3.6 times per year, which supports the importance of developing primary care (PC)-based interventions. The United States Preventive Services Task force (USPSTF) recommends the use of the 5As framework (Assess, Advise, Agree, Assist, Arrange) for counseling patients about weight.
Interactive behavior change technologies utilizing expert system software programs are an innovative way to facilitate 5As counseling to promote behavior change in primary care. These programs perform computerized risk, lifestyle, and theory- based, behavioral assessment to provide computer-generated, tailored advice to patients. They also can provide information to healthcare teams. The MOVE!11 software is an expert system program for VA patients referred to MOVE!, but is not currently used in primary care by Patient-Aligned Care Teams (PACT).
Collaborative goal setting can be used to achieve behavior change in this intervention. This construct, a critical component of several behavior change theories and models and corresponding to "agree" in the 5As model, has been widely recommended for health promotion in primary care. The investigators' formative work (MIRB #01333) using key informant interviews with PACT teamlets and MOVE! staff and focus groups with Veterans demonstrated that goal setting is feasible and acceptable to patients and PACT teamlets and provided insight on barriers to goal setting, and ways to facilitate goal-setting conversations.
During the development phase of this project, the investigators developed a primary care-based intervention called MOVE! Toward Your Goals (MTG) to facilitate weight management within primary care and increase adoption of intensive VA programs such as MOVE!. The PAL intervention uses the MTG software tool (that the investigators developed) delivered on tablets to facilitate 5As-based weight management counseling with a health coach and healthcare team to promote goal-setting, behavior change, and weight loss in the primary care setting. The Veteran also receives follow up with 10-12 health coaching calls over 1 year.
As part of a clustered randomized control trial, the investigators will randomize 17 primary care providers to either Enhanced Usual Care or the PAL Intervention, recruiting 520 subjects.
STUDY OBJECTIVES
- Test the impact of the PAL intervention on weight change and behavioral/clinical outcomes
- Identify predictors of weight loss in Veterans participating in the intervention group related to goal setting processes and intervention components
- Determine the impact of the PAL intervention on obesity-related counseling practices and attitudes
- Conditions
- Obesity, Overweight
- Being tested
- Peer Assisted Lifestyle, Enhanced Usual Care
- Keywords
- obesity, weight loss, weight gain, weight management, primary care, health coach
- Medical subject headings
- Obesity, Overweight, Weight Loss, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Assisted LifestyleBehavioural
Also called PAL arm
Patients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals.
Enhanced Usual CareBehavioural
Also called EUC arm
Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
| Study group | Role | What they receive |
|---|---|---|
| PAL Intervention | Experimental | Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity
Receiving Peer Assisted Lifestyle intervention (PAL tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) Receives: Behavioral: Peer Assisted Lifestyle |
| Enhanced Usual Care (EUC) | Active comparator | Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Weight Change in Kg
Weight change in kg at 12 months
Measured: 12 months
Mean Percent Weight Change From Baseline to 12 Months
Mann-Whitney tests for continuous outcomes (e.g., weight change)
Measured: 12 months
Secondary outcomes (10)
Achievement of 5% Weight Loss
Percent of people in each arm attaining > or = to 5% weight loss
Measured: 6 months
Achievement of 5% Weight Loss
Percent of people in each arm attaining > or = to 5% weight loss
Measured: 12 months
Changes in HB A1C
The investigators will extract HB A1C data from the electronic health record. Due to COVID, participants did not have their regular in-person doctor's appointments to test/collect their HB A1C. Due to a large amount of missing HB A1C data, data was not collected/extracted from the electronic health record and therefore changed in HB A1C was not analyzed.
Measured: 6 and 12 months
Changes in Waist Circumference
To determine whether patients had changes in waist circumference. Adjusted changes between baseline and 6 Months. Mean (SD) of adjusted outcomes in each treatment arm are provided.
Measured: 6 months
Changes in Waist Circumference
To determine whether patients had changes in waist circumference. Adjusted changes between baseline and 12 Months. Mean (SD) of adjusted outcomes in each treatment arm are provided.
Measured: 12 months
Changes in Physical Activity
Measure duration and intensity using accelerometers. The ActiGraph Link (GT9X) accelerometer, worn on the wrist, was used to objectively measure PA for 7 days at Baseline, and at 6 and 12 months.
Measured: 6 and 12 months
Moderate to Vigorous Physical Activity Difference (Minutes)
Measure duration using the Paffenbarger questionnaire items. Difference in adjusted mean behavioral outcome between the treatment arms. Adjusted mean difference (95% Confidence Interval) [p-value] between the treatment arms (PAL - EUC) for each behavioral outcome at 6 months of follow-up.
Measured: 6 months
Moderate to Vigorous Physical Activity Difference (Minutes)
Measure duration using the Paffenbarger questionnaire items. Difference in adjusted mean behavioral outcome between the treatment arms. Adjusted mean difference (95% Confidence Interval) [p-value] between the treatment arms (PAL - EUC) for each behavioral outcome at 12 (primary) months of follow-up.
Measured: 12 months
Percent of People Achieving >150 Minutes of Vigorous to Moderate Physical Activity/Week
Adjusted mean percent of people achieving behavioral outcome in each treatment arms. Measured duration using IPAQ questionnaire items.
Measured: 6 months
Percent of People Achieving >150 Minutes of Vigorous to Moderate Physical Activity/Week
Adjusted mean percent of people achieving behavioral outcome in each treatment arms. Measured duration using IPAQ questionnaire items.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start8 Jan 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Melanie R. Jay, MD MS, Principal investigator, Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163264
- Sponsor's protocol ID
- IIR 15-378
- Other IDs
- 01607
- Acronym
- PAL
- Status last verified
- Nov 2024
- First submitted
- 19 May 2017
- Last updated
- 19 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wittleder S, Smith S, Wang B, Beasley JM, Orstad SL, Sweat V, Squires A, Wong L, Fang Y, Doebrich P, Gutnick D, Tenner C, Sherman SE, Jay M. Peer-Assisted Lifestyle (PAL) intervention: a protocol of a cluster-randomised controlled trial of a health-coaching intervention delivered by veteran peers to improve obesity treatment in primary care. BMJ Open. 2021 Feb 26;11(2):e043013. doi: 10.1136/bmjopen-2020-043013.
PubMed 33637544Wittleder S, Wong L, Ruan AM, Illenberger N, Nicholson A, Portelli D, Cansler R, Tenner CT, Sherman SE, Aguilar AD, Sweat V, Orstad SL, Vandyousefi S, Fronshtein M, Smith S, Dixon A, Goldstein MG, Raffa SD, Wylie-Rosett J, Jay M. Peer Coaching to Support Weight Management in Primary Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2529136. doi: 10.1001/jamanetworkopen.2025.29136.
PubMed 40892413
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of a Technology-assisted Intervention to Improve Weight Management of Obese Patients Within Patient Aligned Care Teams at the VA
- ClinicalTrials.gov ID
- NCT03163264
- Acronym / sponsor ID
- PAL / IIR 15-378
- Conditions
- Obesity, Overweight
- Keywords
- obesity, weight loss, weight gain, weight management, primary care, health coach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 23 May 2017 (actual)
- Results
- Posted 19 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PAL intervention uses a new software tool delivered on tablets to facilitate 5As-based weight management counseling with a peer health coach and the VA PACT healthcare team to promote goal-setting, behavior change, and weight loss in the primary care (PC) setting. The PAL intervention also includes 10-12 health-coaching calls to the patient over 12 months.
As part of a cluster-randomized controlled study, the investigators will randomize 17 primary care providers at the Brooklyn VA to receive either the PAL Intervention or an Enhanced Usual Care control. The primary aim of the study is to explore differences in feasibility, acceptability, and intermediate, behavioral, and weight loss outcomes at 6 and 12 months of 520 patients recruited from the randomized primary care providers.
Objective:
- Explore the feasibility and impact of this intervention on intermediate, behavioral, and weight loss outcomes at 6 and 12 months post-intervention when compared to enhanced usual care.
Detailed description
Veterans shoulder a disproportionate burden of obesity and its co-morbidities, including diabetes, hypertension, and hyperlipidemia. Modest weight loss in obese patients through diet and exercise improves health and prevents chronic disease, but primary care providers (PCPs) often fail to adequately counsel patients about their weight due to lack of time and training. Thus, tools and brief interventions are needed to support providers' behavior change counseling. The VA currently offers the MOVE! program to treat overweight and obese patients, but only 9% of eligible patients attend. At the same time, Veterans on average see their PCPs 3.6 times per year, which supports the importance of developing primary care (PC)-based interventions. The United States Preventive Services Task force (USPSTF) recommends the use of the 5As framework (Assess, Advise, Agree, Assist, Arrange) for counseling patients about weight.
Interactive behavior change technologies utilizing expert system software programs are an innovative way to facilitate 5As counseling to promote behavior change in primary care. These programs perform computerized risk, lifestyle, and theory- based, behavioral assessment to provide computer-generated, tailored advice to patients. They also can provide information to healthcare teams. The MOVE!11 software is an expert system program for VA patients referred to MOVE!, but is not currently used in primary care by Patient-Aligned Care Teams (PACT).
Collaborative goal setting can be used to achieve behavior change in this intervention. This construct, a critical component of several behavior change theories and models and corresponding to "agree" in the 5As model, has been widely recommended for health promotion in primary care. The investigators' formative work (MIRB #01333) using key informant interviews with PACT teamlets and MOVE! staff and focus groups with Veterans demonstrated that goal setting is feasible and acceptable to patients and PACT teamlets and provided insight on barriers to goal setting, and ways to facilitate goal-setting conversations.
During the development phase of this project, the investigators developed a primary care-based intervention called MOVE! Toward Your Goals (MTG) to facilitate weight management within primary care and increase adoption of intensive VA programs such as MOVE!. The PAL intervention uses the MTG software tool (that the investigators developed) delivered on tablets to facilitate 5As-based weight management counseling with a health coach and healthcare team to promote goal-setting, behavior change, and weight loss in the primary care setting. The Veteran also receives follow up with 10-12 health coaching calls over 1 year.
As part of a clustered randomized control trial, the investigators will randomize 17 primary care providers to either Enhanced Usual Care or the PAL Intervention, recruiting 520 subjects.
STUDY OBJECTIVES
- Test the impact of the PAL intervention on weight change and behavioral/clinical outcomes
- Identify predictors of weight loss in Veterans participating in the intervention group related to goal setting processes and intervention components
- Determine the impact of the PAL intervention on obesity-related counseling practices and attitudes
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAL Intervention | Experimental | Behavioral: Peer Assisted LifestyleBody mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Receiving Peer Assisted Lifestyle intervention (PAL tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) |
| Enhanced Usual Care (EUC) | Active comparator | Behavioral: Enhanced Usual CareBody mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-69 (this age range represents MOVE! eligibility)
- BMI of 30kg/m2 or a BMI of 25kg/m2 with obesity-associated condition
- Under the care of PCP with at least 1 prior visit with the provider in the past 24 months
- Access to a telephone
- Able to travel to Brooklyn VA for in-person evaluations at baseline, 6, and 12 months
Key exclusion criteria (7 listed)
- Non-Veterans
- A documented current history of active psychosis, active bipolar disorder, or other cognitive issues via ICD-10 codes
- Undergoing insulin-therapy for diabetes
- Self-reported inability to read at a 5th grade level due to literacy level or vision problems
- Has attended more than 4 MOVE! sessions in the past year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer Assisted LifestyleAlso: PAL armPatients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals. | Behavioural | PAL Intervention |
| Enhanced Usual CareAlso: EUC armPatients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling. | Behavioural | Enhanced Usual Care (EUC) |
Primary outcome
Mean Weight Change in Kg
Time frame: 12 months
Weight change in kg at 12 months
Mean Percent Weight Change From Baseline to 12 Months
Time frame: 12 months
Mann-Whitney tests for continuous outcomes (e.g., weight change)
10 secondary outcomes
Achievement of 5% Weight Loss
Time frame: 6 months
Achievement of 5% Weight Loss
Time frame: 12 months
Changes in HB A1C
Time frame: 6 and 12 months
Changes in Waist Circumference
Time frame: 6 months
Changes in Waist Circumference
Time frame: 12 months
Changes in Physical Activity
Time frame: 6 and 12 months
Moderate to Vigorous Physical Activity Difference (Minutes)
Time frame: 6 months
Moderate to Vigorous Physical Activity Difference (Minutes)
Time frame: 12 months
Percent of People Achieving >150 Minutes of Vigorous to Moderate Physical Activity/Week
Time frame: 6 months
Percent of People Achieving >150 Minutes of Vigorous to Moderate Physical Activity/Week
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33637544Wittleder S, Smith S, Wang B, Beasley JM, Orstad SL, Sweat V, Squires A, Wong L, Fang Y, Doebrich P, Gutnick D, Tenner C, Sherman SE, Jay M. Peer-Assisted Lifestyle (PAL) intervention: a protocol of a cluster-randomised controlled trial of a health-coaching intervention delivered by veteran peers to improve obesity treatment in primary care. BMJ Open. 2021 Feb 26;11(2):e043013. doi: 10.1136/bmjopen-2020-043013.
- Derived from this study: PubMed 40892413Wittleder S, Wong L, Ruan AM, Illenberger N, Nicholson A, Portelli D, Cansler R, Tenner CT, Sherman SE, Aguilar AD, Sweat V, Orstad SL, Vandyousefi S, Fronshtein M, Smith S, Dixon A, Goldstein MG, Raffa SD, Wylie-Rosett J, Jay M. Peer Coaching to Support Weight Management in Primary Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2529136. doi: 10.1001/jamanetworkopen.2025.29136.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie R. Jay, MD MS principal investigator
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Assisted Lifestyle in people with Obesity and Overweight, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Weight Change in Kg (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03163264, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.