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OpenTrials
Completed

NCT Number: NCT00533052

Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment

Behavioral weight loss, the current treatment of choice for moderate obesity, achieves impressive short term results, however, weight regain following treatment is a major problem. Over 50% of participants in behavioral weight loss programs report difficulty with internal antecedents to unhealthy weight control behaviors and this difficulty is associated with weight regain following treatment. Current treatment approaches do not adequately address these antecedents. The aim of this series of studies is to develop, implement, and evaluate a behavioral weight loss program modified to provide participants with skills to deal effectively with affective and cognitive difficulties. The study targets men and women with BMI of 27-40 who self-report difficulty with emotional and/or cognitive antecedents to unhealthy weight control behaviors. The study is an uncontrolled pilot study in 20 participants to initially assess acceptability and efficacy of the innovative treatment. The long-term goal of this research is to improve the weight loss maintenance outcomes of behavioral weight loss programs by addressing affective and cognitive antecedents to unhealthy weight control behaviors.

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Key information

Conditions

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

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Miriam Hospital

Providence, Rhode Island, 02903, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 21 and 70 years
  • Body mass index between 27 and 40
  • Score 5 or above on the internal disinhibition scale of the Eating Inventory

Exclusion criteria

  • Are currently participating in a weight loss program and/or are taking a weight loss medication or lost greater than or equal to 5% of body weight during the past six months
  • Are pregnant, lactating, less than 6 months postpartum or plan to become pregnant during the time frame of the investigation
  • Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.

Treatment and study plan

Affective and Cognitive Skills Training

Behavioral

24-week, weekly, group behavioral weight loss treatment with affective and cognitive skills training

Primary outcomes

  1. Body Mass Index

    Time frame: 6 months

Secondary outcomes

  1. Internal disinhibition as measured by the Eating Inventory

    Time frame: 6 months

    The internal disinhibition subscale of the Eating Inventory ranges from 0 to 8, with high values indicating more disinhibition.

  2. Treatment acceptability based on qualitative feedback

    Time frame: 6 months

  3. Attendance data

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

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

Nih

Collaborators

  • The Miriam Hospital

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 21, 2007
Registry last updated
Mar 14, 2018

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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