OverweightNCT02578199
Novel and Scalable Internet Supplemented Weight Loss Treatment in Primary Care
A study testing motivational interviewing and nutrition in people with Overweight and Obesity, run by Yale University at 1 site in United States.
Trial summary
Motivational interviewing and nutritional counseling for weight loss in primary care. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- motivational interviewing and nutrition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 10 Mar 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI 25-55
- Daily access to internet and phone
- Recruited through local primary care offices.
- Age 18-65
Who cannot join
- Co-existing physical and/or psychiatric conditions that require more significant treatment (e.g., bipolar disorder, psychotic illnesses), and/or require more intensive treatment or hospitalization (e.g., suicidality, severe mood disorders)
- Meets criteria for current substance abuse/dependence
- Currently receiving psychiatric, psychological, behavioral, or pharmacologic treatment that is known to affect weight or eating
- Pregnant, breastfeeding, or plans to become pregnant during the treatment period
- Cardiac disease, including ischemic heart disease, congestive heart failure, conduction abnormalities, or a history of heart attack
- Serious neurologic illnesses (e.g., seizure history) or medical illnesses (e.g., impaired hepatic or renal function)
- Uncontrolled diabetes, thyroid conditions, or hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06520
About this study
Motivational interviewing and nutritional counseling for weight loss in primary care.
Read the detailed description
Overweight and obese participants will be recruited through local primary care offices. This study will test the effectiveness of motivational interviewing and nutritional counseling for weight loss. The treatment will be supplemented by internet support.
- Conditions
- Overweight, Obesity
- Being tested
- motivational interviewing and nutrition
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational interviewing and nutritionBehavioural
Motivational Interviewing and Nutritional Counseling
| Study group | Role | What they receive |
|---|---|---|
| motivational interviewing and nutrition | Experimental | Motivational interviewing and nutritional counseling. Receives: Behavioral: motivational interviewing and nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight in Pounds
Body weight in pounds measured 3 months after starting treatment.
Measured: 3 months
Secondary outcomes (1)
Body Weight in Pounds
Body weight in pounds measured 6 months after starting treatment (3 month follow-up after active treatment ends).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startDec 2015
- Primary completion2 Dec 2016
- Study completion10 Mar 2017
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 (3)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Barnes, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578199
- Sponsor's protocol ID
- 1106008713-B
- Other IDs
- R03DK104008-01
- Status last verified
- Nov 2016
- First submitted
- 14 Oct 2015
- Last updated
- 30 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Barnes RD, Ivezaj V, Martino S, Pittman BP, Paris M, Grilo CM. 12 Months later: Motivational interviewing plus nutrition psychoeducation for weight loss in primary care. Eat Weight Disord. 2021 Aug;26(6):2077-2081. doi: 10.1007/s40519-020-00994-5. Epub 2020 Sep 7.
PubMed 32894453Barnes RD, Ivezaj V, Martino S, Pittman BP, Paris M, Grilo CM. Examining motivational interviewing plus nutrition psychoeducation for weight loss in primary care. J Psychosom Res. 2018 Jan;104:101-107. doi: 10.1016/j.jpsychores.2017.11.013. Epub 2017 Nov 28.
PubMed 29275778Barnes RD, Ivezaj V, Martino S, Pittman BP, Grilo CM. Back to Basics? No Weight Loss from Motivational Interviewing Compared to Nutrition Psychoeducation at One-Year Follow-Up. Obesity (Silver Spring). 2017 Dec;25(12):2074-2078. doi: 10.1002/oby.21972. Epub 2017 Oct 31.
PubMed 29086484
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel and Scalable Internet Supplemented Weight Loss Treatment in Primary Care
- ClinicalTrials.gov ID
- NCT02578199
- Acronym / sponsor ID
- 1106008713-B
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Dec 2015
- Primary completion
- 2 Dec 2016 (actual)
- Study completion
- 10 Mar 2017 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Posted 1 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Motivational interviewing and nutritional counseling for weight loss in primary care.
Detailed description
Overweight and obese participants will be recruited through local primary care offices. This study will test the effectiveness of motivational interviewing and nutritional counseling for weight loss. The treatment will be supplemented by internet support.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| motivational interviewing and nutrition | Experimental | Behavioral: motivational interviewing and nutritionMotivational interviewing and nutritional counseling. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI 25-55
- Daily access to internet and phone
- Recruited through local primary care offices.
- Age 18-65
Key exclusion criteria (7 listed)
- Co-existing physical and/or psychiatric conditions that require more significant treatment (e.g., bipolar disorder, psychotic illnesses), and/or require more intensive treatment or hospitalization (e.g., suicidality, severe mood disorders)
- Meets criteria for current substance abuse/dependence
- Currently receiving psychiatric, psychological, behavioral, or pharmacologic treatment that is known to affect weight or eating
- Pregnant, breastfeeding, or plans to become pregnant during the treatment period
- Cardiac disease, including ischemic heart disease, congestive heart failure, conduction abnormalities, or a history of heart attack
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 interviewing and nutritionMotivational Interviewing and Nutritional Counseling | Behavioural | motivational interviewing and nutrition |
Primary outcome
Body Weight in Pounds
Time frame: 3 months
Body weight in pounds measured 3 months after starting treatment.
1 secondary outcome
Body Weight in Pounds
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32894453Barnes RD, Ivezaj V, Martino S, Pittman BP, Paris M, Grilo CM. 12 Months later: Motivational interviewing plus nutrition psychoeducation for weight loss in primary care. Eat Weight Disord. 2021 Aug;26(6):2077-2081. doi: 10.1007/s40519-020-00994-5. Epub 2020 Sep 7.
- Derived from this study: PubMed 29275778Barnes RD, Ivezaj V, Martino S, Pittman BP, Paris M, Grilo CM. Examining motivational interviewing plus nutrition psychoeducation for weight loss in primary care. J Psychosom Res. 2018 Jan;104:101-107. doi: 10.1016/j.jpsychores.2017.11.013. Epub 2017 Nov 28.
- Derived from this study: PubMed 29086484Barnes RD, Ivezaj V, Martino S, Pittman BP, Grilo CM. Back to Basics? No Weight Loss from Motivational Interviewing Compared to Nutrition Psychoeducation at One-Year Follow-Up. Obesity (Silver Spring). 2017 Dec;25(12):2074-2078. doi: 10.1002/oby.21972. Epub 2017 Oct 31.
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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.
Rachel Barnes, Ph.D. principal investigator
Yale 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 interviewing and nutrition in people with Overweight and Obesity, run by Yale University 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 4 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 30 Mar 2020. 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 1 Aug 2017). 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?
Body Weight in Pounds (time frame: 3 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 NCT02578199, which also lists 3 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 30 Mar 2020.