OverweightNCT01558297

Internet Treatment for Weight Loss in Primary Care

A study testing Motivational Interviewing, Nutritional Counseling and Treatment as usual with primary care physician in people with Overweight and Obese, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will test the effectiveness of two distinct treatments for weight loss: 1. Motivational Interviewing 2. Nutritional Counseling. These treatments will be compared to Treatment as Usual. Participants will be recruited through local primary care offices. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Overweight, Obese
What is being tested?: Motivational Interviewing, Nutritional Counseling and Treatment as usual with primary care physician
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 89 participants
Where: 1 siteUnited States
Study dates: Apr 2012to May 2013
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

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 or 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

Other trials in United States

About this study

This study will test the effectiveness of two distinct treatments for weight loss:

Motivational Interviewing
Nutritional Counseling. These treatments will be compared to Treatment as Usual. Participants will be recruited through local primary care offices.

Conditions: Overweight, Obese
Being tested: Motivational Interviewing, Nutritional Counseling, Treatment as usual with primary care physician
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 InterviewingBehavioural
5 sessions of motivational interviewing over a period of 3 months.
Nutritional CounselingBehavioural
5 sessions of nutritional counseling over a period of 3 months.
Treatment as usual with primary care physicianBehavioural
Participants will be encouraged to continue their care with their primary care physician.

Study groups in NCT01558297
Study group	Role	What they receive
Motivational Interviewing	Experimental	Not described Receives: Behavioral: Motivational Interviewing
Nutritional Counseling	Active comparator	Not described Receives: Behavioral: Nutritional Counseling
Treatment as usual	Active comparator	Not described Receives: Behavioral: Treatment as usual with primary care physician

What is being measured

The primary outcome is the main question the study is designed to answer.

Body Weight in Pounds.
Body weight lost in pounds measured 1.5 months after first treatment session.
Measured: 1.5 months after treatment start (Baseline)
Body Weight in Pounds.
Body weight lost in pounds measured 3 months after first treatment session.
Measured: 3 months after treatment start (Baseline)
Body Weight in Pounds.
Body weight lost in pounds measured 6 months after first treatment session (3 month follow-up after active treatment ends).
Measured: 6 months after treatment start (Baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012May 2013

First posted20 Mar 2012 (estimated)
Study startApr 2012
Primary completionMay 2013
Study completionMay 2013

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 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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01558297
Sponsor's protocol ID: 1106008713
Other IDs: 1K23DK092279-01
Status last verified: Jun 2015
First submitted: 15 Mar 2012
Last updated: 1 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Barnes RD, White MA, Martino S, Grilo CM. A randomized controlled trial comparing scalable weight loss treatments in primary care. Obesity (Silver Spring). 2014 Dec;22(12):2508-16. doi: 10.1002/oby.20889. Epub 2014 Oct 9.
PubMed 25298016
Wiedemann AA, Baumgardt SS, Ivezaj V, Kerrigan SG, Lydecker JA, Grilo CM, Barnes RD. Getting a head start: identifying pretreatment correlates associated with early weight loss for individuals participating in weight loss treatment. Transl Behav Med. 2021 Feb 11;11(1):236-243. doi: 10.1093/tbm/ibz149.
PubMed 31816053

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Internet Treatment for Weight Loss in Primary Care
ClinicalTrials.gov ID: NCT01558297
Acronym / sponsor ID: 1106008713
Conditions: Overweight, Obese
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: Apr 2012
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 20 Mar 2012 (estimated)
Results: Posted 4 Jun 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will test the effectiveness of two distinct treatments for weight loss:

Motivational Interviewing
Nutritional Counseling. These treatments will be compared to Treatment as Usual. Participants will be recruited through local primary care offices.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Motivational Interviewing	Experimental	Behavioral: Motivational Interviewing
Nutritional Counseling	Active comparator	Behavioral: Nutritional Counseling
Treatment as usual	Active comparator	Behavioral: Treatment as usual with primary care physician

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

BMI 25-55
Daily access to internet and phone

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 or 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 Interviewing5 sessions of motivational interviewing over a period of 3 months.	Behavioural	Motivational Interviewing
Nutritional Counseling5 sessions of nutritional counseling over a period of 3 months.	Behavioural	Nutritional Counseling
Treatment as usual with primary care physicianParticipants will be encouraged to continue their care with their primary care physician.	Behavioural	Treatment as usual

Primary outcome

Body Weight in Pounds.
Time frame: 1.5 months after treatment start (Baseline)
Body weight lost in pounds measured 1.5 months after first treatment session.
Body Weight in Pounds.
Time frame: 3 months after treatment start (Baseline)
Body weight lost in pounds measured 3 months after first treatment session.
Body Weight in Pounds.
Time frame: 6 months after treatment start (Baseline)
Body weight lost in pounds measured 6 months after first treatment session (3 month follow-up after active treatment ends).

Results and safety

Results posted to the registry on 4 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Motivational Interviewing	30	28
Nutritional Counseling	29	27
Treatment as Usual	30	29

Primary outcome: Body Weight in Pounds.

Time frame: 1.5 months after treatment start (Baseline). Mean (Standard Deviation). Unit: pounds

Measure	Motivational Interviewing n = 30	Nutritional Counseling n = 29	Treatment as Usual n = 30
Value	-3.1 (4.6)	-3.4 (5.2)	0.1 (3.5)

Population analysed: Intent-to-treat data are presented, with the last observation carried forward, and outliers beyond 3 standard deviations replaced with highest recorded value within the 3 standard deviation range.

Primary outcome: Body Weight in Pounds.

Time frame: 3 months after treatment start (Baseline). Mean (Standard Deviation). Unit: pounds

Measure	Motivational Interviewing n = 30	Nutritional Counseling n = 29	Treatment as Usual n = 30
Value	-3.3 (6.5)	-4.9 (6.1)	-0.4 (6.2)

Primary outcome: Body Weight in Pounds.

Time frame: 6 months after treatment start (Baseline). Mean (Standard Deviation). Unit: pounds

Measure	Motivational Interviewing n = 30	Nutritional Counseling n = 29	Treatment as Usual n = 30
Value	-2.6 (8.7)	-5.7 (9.0)	0.4 (7.2)

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Motivational Interviewing	0 of 30 (0%)	0 of 30 (0%)	Not reported
Nutritional Counseling	0 of 29 (0%)	0 of 30 (0%)	Not reported
Treatment as Usual	0 of 30 (0%)	0 of 30 (0%)	Not reported

Limitations and caveats (from the sponsor): Treatment as Usual (TAU) was subsequently referred to as Usual Care (UC) when the study results were disseminated because the literature evolved regarding treatment terms. UC more accurately reflect the condition.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25298016Barnes RD, White MA, Martino S, Grilo CM. A randomized controlled trial comparing scalable weight loss treatments in primary care. Obesity (Silver Spring). 2014 Dec;22(12):2508-16. doi: 10.1002/oby.20889. Epub 2014 Oct 9.
Derived from this study: PubMed 31816053Wiedemann AA, Baumgardt SS, Ivezaj V, Kerrigan SG, Lydecker JA, Grilo CM, Barnes RD. Getting a head start: identifying pretreatment correlates associated with early weight loss for individuals participating in weight loss treatment. Transl Behav Med. 2021 Feb 11;11(1):236-243. doi: 10.1093/tbm/ibz149.

Related trials for Overweight

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
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Recruiting
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Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
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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, PhD 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?

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 2 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 1 Jul 2015. 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 4 Jun 2015). 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: 1.5 months after treatment start (Baseline)). The study lists 3 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 NCT01558297, 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 1 Jul 2015.