ObesityNCT02708121
Increasing Uptake of Behavioral Weight Loss Programs Among Primary Care Patients
A study testing Motivational Intervention and Comparator Intervention in people with Obesity, run by University of Florida at 1 site in United States.
Trial summary
This pilot trial will test feasibility and acceptability of a primary care-based intervention that aims to increase the portion of patients who enter evidence-based behavioral weight loss treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- Motivational Intervention and Comparator Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2017to 23 Feb 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Primary care provider Inclusion criteria:
- Employed by Duke PCRC clinic as primary care provider at least ½ FTE.
- Has a primary adult panel
- Has worked at Duke PCRC clinic for at least one year
Patient inclusion criteria
- BMI ≥ 30 kg/m2 as measured at any clinic in previous 12 months.
- English speaking
- Self-report BMI ≥ 29 kg/m2 (to allow for under-reporting)
- Regular email usage, defined as accessing email 3 or more times per week (on home or work computer or cell phone)
- Age 18-75
- Clinical appointment (well visit or chronic care visit) with enrolled Duke provider in 2-6 weeks of record review.
- At least one prior appointment with the provider they are scheduled to see at target clinical appt.
- Has a valid email address in electronic health records.
Patient exclusion criteria:
- In weight loss treatment program in past year
- Unable to read content on websites without any assistance
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
This pilot trial will test feasibility and acceptability of a primary care-based intervention that aims to increase the portion of patients who enter evidence-based behavioral weight loss treatment.
Read the detailed description
This trial is a pilot, pragmatic cluster randomized trial conducted in primary care clinics to determine intervention acceptability and the feasibility of proposed study protocol.
- Conditions
- Obesity
- Being tested
- Motivational Intervention, Comparator Intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterventionBehavioural
Also called Your Wellness Prescription
Participants complete web-based assessment and receive tailored feedback to motivate weight loss treatment initiation and informed that they have access to weight loss treatment.
Comparator InterventionOther
Participants informed that they have access to weight loss treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Participant receives intervention to motivate weight loss treatment initiation and access to weight loss treatment. Receives: Behavioral: Motivational Intervention |
| Comparator Arm | Active comparator | Participant receives access to weight loss treatment alone. Receives: Other: Comparator Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Attending 6 Month Follow-up Appointment
Count of enrolled participants who attend 6 month follow-up appointment
Measured: 6 months
Secondary outcomes (1)
Intervention Acceptability (Acceptability Outcome)
Ratings on series of items developed by study team to assess patient perception of acceptability of the intervention. Items were created by study team. Possible range of 1 (strongly disagree) to 5 (strongly agree). Higher score reflects greater acceptability except for item 11.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study start3 Mar 2017
- Primary completion23 Feb 2018
- Study completion23 Feb 2018
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 (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan A McVay, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708121
- Sponsor's protocol ID
- IRB201701301-N
- Other IDs
- 1K23HL127334, Pro00079803
- Status last verified
- Jun 2019
- First submitted
- 10 Mar 2016
- Last updated
- 25 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
McVay MA, Yancy WS, Bennett GG, Levine E, Jung SH, Jung S, Anton S, Voils CI. A web-based intervention to increase weight loss treatment initiation: results of a cluster randomized feasibility and acceptability trial. Transl Behav Med. 2021 Feb 11;11(1):226-235. doi: 10.1093/tbm/ibz143.
PubMed 31586443
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Uptake of Behavioral Weight Loss Programs Among Primary Care Patients
- ClinicalTrials.gov ID
- NCT02708121
- Acronym / sponsor ID
- IRB201701301-N
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Duke University
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 23 Feb 2018 (actual)
- Study completion
- 23 Feb 2018 (actual)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Posted 15 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot trial will test feasibility and acceptability of a primary care-based intervention that aims to increase the portion of patients who enter evidence-based behavioral weight loss treatment.
Detailed description
This trial is a pilot, pragmatic cluster randomized trial conducted in primary care clinics to determine intervention acceptability and the feasibility of proposed study protocol.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Motivational InterventionParticipant receives intervention to motivate weight loss treatment initiation and access to weight loss treatment. |
| Comparator Arm | Active comparator | Other: Comparator InterventionParticipant receives access to weight loss treatment alone. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Motivational InterventionAlso: Your Wellness PrescriptionParticipants complete web-based assessment and receive tailored feedback to motivate weight loss treatment initiation and informed that they have access to weight loss treatment. | Behavioural | Intervention arm |
| Comparator InterventionParticipants informed that they have access to weight loss treatment. | Other | Comparator Arm |
Primary outcome
Number of Participants Attending 6 Month Follow-up Appointment
Time frame: 6 months
Count of enrolled participants who attend 6 month follow-up appointment
1 secondary outcome
Intervention Acceptability (Acceptability Outcome)
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31586443McVay MA, Yancy WS, Bennett GG, Levine E, Jung SH, Jung S, Anton S, Voils CI. A web-based intervention to increase weight loss treatment initiation: results of a cluster randomized feasibility and acceptability trial. Transl Behav Med. 2021 Feb 11;11(1):226-235. doi: 10.1093/tbm/ibz143.
- Individual participant dataSharing planned: Undecided
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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.
Megan A McVay, PhD principal investigator
Duke 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 Motivational Intervention and Comparator Intervention in people with Obesity, run by University of Florida 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?
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 25 Jun 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?
Yes. Results are posted in the registry (first posted 15 Feb 2019). 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?
Number of Participants Attending 6 Month Follow-up Appointment (time frame: 6 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 NCT02708121, 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 25 Jun 2019.