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Completed

NCT Number: NCT00896194

Self-Efficacy in Weight Loss Treatment

This randomized clinical trial of weight loss treatment will examine if adding personalized, one-on-one treatment session to standard behavioral group treatment will result in greater weight loss, less weight regain after weight loss, and better adherence to the treatment protocol.

Everyone who enrolls in the study will receive information on healthy eating, how to increase their physical activity and develop healthy exercise habits and ways to change their eating so that they will lose weight. This information will be provided at evening group sessions. There will be a total of 20 group meetings over an 18-month period that will be held:

* every week during the first month of the study, * every other week for the second month * once a month for months 3-12 * every 6 weeks for months 13-18

Participants in the self-efficacy group will also be asked to participate in one-on-one lifestyle counseling sessions with a study interventionist throughout the study.

Everyone will be asked to complete questionnaires, two 24-hour dietary recalls over the phone, and have blood tests done every six months (at the beginning of the study, at 6, 12, and 18 months) a total of 4 times for the study.

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Key information

Conditions

Overweight Behavior Body Weight Health Behavior Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh School of Nursing

Pittsburgh, Pennsylvania, 15261, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • age 18 years or older
  • BMI > 27 and < 43
  • willing to be randomized to one of the two treatment conditions
  • successful completion of screening requiring 5-day recording of food intake in a paper diary
  • have at least two risk factors for coronary heart disease, e.g., overweight or obese, hypertension, dyslipidemia, positive family history (first degree relative)

NOTE: Although residing in Western Pennsylvania is not an explicit eligibility criterion, participants are asked to travel to the University of Pittsburgh frequently (weekly for the first month)

Exclusion criteria

  • presence of a current serious illness or unstable condition requiring physician-supervised diet and exercise (e.g., diabetes, recent acute myocardial infarction) for which physician supervision of diet and physical activity prescription is needed
  • physical limitations precluding ability to engage in physical activity at moderate intensity
  • pregnancy or intention to become pregnant in the next 18 months
  • current treatment for a psychological disorder
  • reported alcohol intake > 4 drinks/day
  • previous participation in a formal weight loss program within the past 5 years, e.g., Weight Watchers or a research program, or current use of weight loss medication
  • planned extended vacations, absences, or relocation within the next 18 months

Treatment and study plan

Standard Behavioral Treatment

Behavioral

SBT consists of group counseling sessions where participants learn about healthy eating and physical activity. Participants are also given standard calorie goals, fat gram goals, and physical activity goals (minutes).

Modified Standard Behavioral Intervention + Self-Efficacy

Behavioral

This group receives identical group intervention sessions. The goals (calories, fat grams, and physical activity minutes) are tailored to the individual's progress. Participants meet regularly with an interventionist for one-on-one lifestyle counseling.

Primary outcomes

  1. Weight

    Time frame: 12 and 18 months post enrollment

Secondary outcomes

  1. Health-related quality of life

    Time frame: 12 and 18 months post enrollment

  2. Adherence to treatment protocol

    Time frame: 12 and 18 months post enrollment

Sponsors and collaborators

Lead sponsor

Lora Burke

Other

Registry information

Acronym: SELF

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
May 11, 2009
Registry last updated
Jul 7, 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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