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Completed

NCT Number: NCT02501239

Health At Every Size and Acceptance and Commitment Therapy vs. Behavioral Weight Loss for Obesity and Depression in Women

The primary aim of this project is to conduct a randomized controlled pilot study evaluating the feasibility and potential effectiveness of a newly developed combined Health At Every Size and Acceptance and Commitment Therapy (HAES/ACT) treatment, known as Accept Yourself! compared to a commercial behavioral weight loss program, Weight Watchers (WW). Obese women (BMI ≥ 30) with Major Depressive Disorder will be randomly assigned to one of these two treatments. Depression, physical health, and other psychosocial outcomes will be assessed prior to treatment, at post-treatment, and at 3, 6, 9, and 12-month follow up assessments.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • English-speaking
  • Major Depressive Disorder (assessed using the Structured Clinical Interview for DSM-IV, SCID-IV)
  • Body Mass Index (BMI) greater than or equal to 30
  • Not taking medications or on stable medication regimens (i.e. no medication changes for six weeks prior to enrollment or during the study)

Exclusion criteria

  • current substance dependence
  • history of psychotic symptoms
  • high risk of suicide/self-harm
  • current enrollment in a weight-loss program
  • weight loss surgery in the past year
  • current psychotherapy
  • inability to postpone weight loss or depression treatment interventions for the duration of the study
  • taking antipsychotic, tricyclic, or oral corticosteroid medication
  • unwilling to be randomized to the study treatments

Treatment and study plan

Accept Yourself!

Behavioral

Other names: HAES/ACT

Weight Watchers

Behavioral

Primary outcomes

  1. Change in clinician assessed depression symptoms

    Time frame: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.

    As assessed by clinician rated Hamilton Depression Rating Scale (HAM-D)

  2. Change in self-reported depression symptoms

    Time frame: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.

    As assessed by Patient Health Questionnaire-9 (PHQ-9)

Secondary outcomes

  1. Change in fasting Lipids

    Time frame: At post-treatment (immediately following the three-month intervention) and at 12 month follow-up.

  2. Change in systolic and diastolic blood pressure

    Time frame: At post-treatment (immediately following the three-month intervention) and 12 month follow up

  3. Change in fasting blood glucose

    Time frame: At post-treatment (immediately following the three-month intervention) and 12 month follow up

  4. Change in eating disorder symptoms, measured by the Eating Disorders Diagnostic Scale (EDDS)

    Time frame: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.

  5. Change in obesity-related quality of life, measured by the Obesity-Related Well-Being Questionnaire (ORWELL97)

    Time frame: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.

  6. Change in obesity stigma, measured by the Weight Self-Stigma Questionnaire (WSSQ)

    Time frame: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.

  7. Number of participants who did not complete an adequate dose of the intervention (at least 7 group visits)

    Time frame: At post-treatment (immediately following the three-month intervention)

  8. Change in weight

    Time frame: At post-treatment (immediately following the three-month intervention) and 12 month follow up

    Note that we are assessing weight change primarily as a safety measure (i.e., to demonstrate no significant weight gain in intervention group).

  9. Change in self-reported physical activity

    Time frame: At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.

  10. Change in cardiovascular fitness as assessed by six-minute walk test

    Time frame: At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Hitchcock Foundation

Registry information

Official study title

Health At Every Size and Acceptance and Commitment Therapy vs. Behavioral Weight Loss for Obesity and Depression in Women: A Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 17, 2015
Registry last updated
Apr 26, 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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