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OpenTrials
Completed

NCT Number: NCT01558297

Internet Treatment for Weight Loss in Primary Care

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Motivational Interviewing

Behavioral

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

Nutritional counseling

Behavioral

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

Treatment as usual with primary care physician

Behavioral

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

Primary outcomes

  1. 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.

  2. Body Weight in Pounds.

    Time frame: 3 months after treatment start (Baseline)

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

  3. 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).

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 20, 2012
Registry last updated
Jul 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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