ObesityNCT01642199
Lay Health Coaches for Weight Loss: Peers Versus Mentors
A study testing Reduced Intensity Behavioral Weight Loss + Peer Health Coach, Reduced Intensity Behavioral Weight Loss + Mentor Health Coach and Reduced Intensity Behavioral Weight Loss in people with Obesity, run by University of Connecticut at 1 site in United States.
Trial summary
The primary aim of this study is to determine whether reduced intensity behavioral weight loss treatment (rBWL) + Peer Health Coaches yields significantly greater weight loss than rBWL + Mentor Health Coaches and rBWL alone. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Reduced Intensity Behavioral Weight Loss + Peer Health Coach, Reduced Intensity Behavioral Weight Loss + Mentor Health Coach and Reduced Intensity Behavioral Weight Loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index between 30 and 40
- Age between 40 and 60 years
- English speaking
Who cannot join
- Are unwilling to communicate regularly with a weight loss coach
- Report not being able to walk 2 blocks (1/4 mile) without stopping
- Are currently participating in a weight loss program, taking a weight loss medication, have a history of bariatric surgery, or lost ≥ 5% of body weight during the past 6-months
- Are pregnant, lactating, less than 6-months post-partum, or plan to become pregnant during the intervention timeframe
- Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
- Report a medical condition that would jeopardize their safety if involved in a weight management program with diet and exercise guidelines
- Report conditions that, in the judgment of the PI, would render the participant unlikely to follow the study protocol (e.g., relocation, dementia, terminal illness, substance abuse).
Trial locations and contacts
1 site in 1 country.
United States1 site
The Miriam Hospital's Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
About this study
Official title: A Randomized Trial Testing Lay Health Coaches for Obesity Treatment
The primary aim of this study is to determine whether reduced intensity behavioral weight loss treatment (rBWL) + Peer Health Coaches yields significantly greater weight loss than rBWL + Mentor Health Coaches and rBWL alone.
- Conditions
- Obesity
- Being tested
- Reduced Intensity Behavioral Weight Loss + Peer Health Coach, Reduced Intensity Behavioral Weight Loss + Mentor Health Coach, Reduced Intensity Behavioral Weight Loss
- Keywords
- obesity, weight loss, lay health coach, peer coach, mentor coach, reduced intensity weight loss program
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced Intensity Behavioral Weight Loss + Peer Health CoachBehavioural
Participants will receive a 12-month reduced intensity group behavioral weight loss program. During weeks that there are no group meetings, participants will be coached by peers (i.e., other members of their weight loss group).
Reduced Intensity Behavioral Weight Loss + Mentor Health CoachBehavioural
Participants will receive a 12-month reduced intensity group behavioral weight loss program. During weeks that there are no group meetings, participants will be coached by a mentor (i.e., successful weight loser).
Reduced Intensity Behavioral Weight LossBehavioural
Participants will receive 12 months of a reduced intensity group behavioral weight loss program.
| Study group | Role | What they receive |
|---|---|---|
| Reduced Intensity Behavioral Weight Loss + Peer Health Coach | Active comparator | Not described Receives: Behavioral: Reduced Intensity Behavioral Weight Loss + Peer Health Coach |
| Reduced Intensity Behavioral Weight Loss + Mentor Health Coach | Active comparator | Not described Receives: Behavioral: Reduced Intensity Behavioral Weight Loss + Mentor Health Coach |
| Reduced Intensity Behavioral Weight Loss | Active comparator | Not described Receives: Behavioral: Reduced Intensity Behavioral Weight Loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change from the initial assessment to the 12-month assessment measured on a digital scale to the nearest 0.1-kilogram
Measured: baseline to 12 months
Secondary outcomes (1)
Direction of social comparison between participants and their Peer or Mentor weight loss coach
Participants in rBWL + Peer and rBWL + Mentor will complete a questionnaire that assesses whether their progress on weight loss, diet, and activity are "worse," "similar to," or "better" than their coach's on a 5-point likert scale. Mean scores on this measure will be reported.
Measured: 2-weeks, 3-months, 6-months, 9-months, and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startJan 2013
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tricia Leahey, University of Connecticut
- Investigators
- Tricia M Leahey, PhD, Principal investigator, The Miriam Hospital / Warren Alpert Medical School at Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642199
- Sponsor's protocol ID
- 1R01DK095771-01
- Status last verified
- Oct 2019
- First submitted
- 12 Jul 2012
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Leahey TM, Huedo-Medina TB, Grenga A, Gay L, Fernandes D, Denmat Z, Doyle C, Areny-Joval R, Wing RR. Patient-provided e-support in reduced intensity obesity treatment: The INSPIRE randomized controlled trial. Health Psychol. 2020 Dec;39(12):1037-1047. doi: 10.1037/hea0000996.
PubMed 33252929
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Testing Lay Health Coaches for Obesity Treatment
- ClinicalTrials.gov ID
- NCT01642199
- Acronym / sponsor ID
- 1R01DK095771-01
- Conditions
- Obesity
- Keywords
- obesity, weight loss, lay health coach, peer coach, mentor coach, reduced intensity weight loss program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2013
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 17 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to determine whether reduced intensity behavioral weight loss treatment (rBWL) + Peer Health Coaches yields significantly greater weight loss than rBWL + Mentor Health Coaches and rBWL alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reduced Intensity Behavioral Weight Loss + Peer Health Coach | Active comparator | Behavioral: Reduced Intensity Behavioral Weight Loss + Peer Health Coach |
| Reduced Intensity Behavioral Weight Loss + Mentor Health Coach | Active comparator | Behavioral: Reduced Intensity Behavioral Weight Loss + Mentor Health Coach |
| Reduced Intensity Behavioral Weight Loss | Active comparator | Behavioral: Reduced Intensity Behavioral Weight Loss |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body Mass Index between 30 and 40
- Age between 40 and 60 years
- English speaking
Key exclusion criteria (7 listed)
- Are unwilling to communicate regularly with a weight loss coach
- Report not being able to walk 2 blocks (1/4 mile) without stopping
- Are currently participating in a weight loss program, taking a weight loss medication, have a history of bariatric surgery, or lost ≥ 5% of body weight during the past 6-months
- Are pregnant, lactating, less than 6-months post-partum, or plan to become pregnant during the intervention timeframe
- Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
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 |
|---|---|---|
| Reduced Intensity Behavioral Weight Loss + Peer Health CoachParticipants will receive a 12-month reduced intensity group behavioral weight loss program. During weeks that there are no group meetings, participants will be coached by peers (i.e., other members of their weight loss group). | Behavioural | Reduced Intensity Behavioral Weight Loss + Peer Health Coach |
| Reduced Intensity Behavioral Weight Loss + Mentor Health CoachParticipants will receive a 12-month reduced intensity group behavioral weight loss program. During weeks that there are no group meetings, participants will be coached by a mentor (i.e., successful weight loser). | Behavioural | Reduced Intensity Behavioral Weight Loss + Mentor Health Coach |
| Reduced Intensity Behavioral Weight LossParticipants will receive 12 months of a reduced intensity group behavioral weight loss program. | Behavioural | Reduced Intensity Behavioral Weight Loss |
Primary outcome
Weight change from the initial assessment to the 12-month assessment measured on a digital scale to the nearest 0.1-kilogram
Time frame: baseline to 12 months
1 secondary outcome
Direction of social comparison between participants and their Peer or Mentor weight loss coach
Time frame: 2-weeks, 3-months, 6-months, 9-months, and 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Derived from this study: PubMed 33252929Leahey TM, Huedo-Medina TB, Grenga A, Gay L, Fernandes D, Denmat Z, Doyle C, Areny-Joval R, Wing RR. Patient-provided e-support in reduced intensity obesity treatment: The INSPIRE randomized controlled trial. Health Psychol. 2020 Dec;39(12):1037-1047. doi: 10.1037/hea0000996.
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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.
Tricia M Leahey, PhD principal investigator
The Miriam Hospital / Warren Alpert Medical School at Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced Intensity Behavioral Weight Loss + Peer Health Coach, Reduced Intensity Behavioral Weight Loss + Mentor Health Coach and Reduced Intensity Behavioral Weight Loss in people with Obesity, run by University of Connecticut 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 3 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 3 Oct 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Weight change from the initial assessment to the 12-month assessment measured on a digital scale to the nearest 0.1-kilogram (time frame: baseline to 12 months). 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 NCT01642199, which also lists 1 linked publication.
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 3 Oct 2019.