Internet Treatment for Weight Loss in Primary Care

NCT01558297 | Completed Results DMC

• 2 other identifiers: 11060087131K23DK092279-01
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Overweight; Obese

Outcome Measures

Primary Outcomes (3)

• Body Weight in Pounds.

  Body weight lost in pounds measured 1.5 months after first treatment session.

  1.5 months after treatment start (Baseline)

• Body Weight in Pounds.

  Body weight lost in pounds measured 3 months after first treatment session.

  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).

  6 months after treatment start (Baseline)

Study Arms (3)

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

Interventions

Motivational Interviewing BEHAVIORAL

5 sessions of motivational interviewing over a period of 3 months.

Motivational Interviewing

Nutritional Counseling BEHAVIORAL

5 sessions of nutritional counseling over a period of 3 months.

Nutritional Counseling

Treatment as usual with primary care physician BEHAVIORAL

Participants will be encouraged to continue their care with their primary care physician.

Treatment as usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI 25-55
• Daily access to internet and phone

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

Related Publications (2)

• 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.

  PMID: 25298016 RESULT

• 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.

  PMID: 31816053 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Motivational Interviewing; Nutrition Assessment; Therapeutics; Physicians, Primary Care

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Physicians; Health Personnel

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Rachel Barnes
• Organization: Yale Medical School

rachel.barnes@yale.edu

2037856395

Study Officials

• Rachel Barnes, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Scienist

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: March 20, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 1, 2015
• Results First Posted: June 4, 2015

Record last verified: 2015-06

Locations

US (1)