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OpenTrials
Completed

NCT Number: NCT01858714

Environmental and Acceptance-Based Innovations for Weight Loss Maintenance

The major goal of this project is to evaluate an innovative approach to obesity involving modification of the home environment. The project also will evaluate if home environment modification is more effective when supplemented with distress tolerance and related skills training.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have a BMI between 27 and 45 kg/m2
  • Have the ability to engage in physical activity (i.e., can walk at least 2 blocks without stopping for rest)
  • Successfully complete all steps in the enrollment process, including completion of a 7-day food diary and attendance at all pre-randomization clinic visits

Exclusion criteria

  • Have a medical condition (e.g., cancer) or psychiatric condition (e.g., psychotic disorder, substance dependence, bulimia nervosa) that may limit their ability to comply with the behavioral recommendations of the program or pose a risk to the participant during weight loss
  • Are pregnant or plan to become pregnant in next 2 years
  • Report recently beginning a course of or changing the dosage of prescription medications that can cause significant weight loss or weight gain
  • Are participating in or plan to participate in another weight loss program in the next 2 years

Treatment and study plan

Behavior Therapy for Weight Loss

Behavioral

Standard behavioral treatment for weight loss and weight loss maintenance.

Behavior Therapy + Environment

Behavioral

Standard behavioral therapy with an emphasis on environmental strategies.

Acceptance-based Behavior Therapy + Environment

Behavioral

Behavioral therapy with acceptance-based and environmental strategies.

Primary outcomes

  1. Change in Body Weight

    Time frame: Baseline, 6 months, 12 months, 18 months, 24 months

  2. Change in Physical Activity

    Time frame: Baseline, 6 months, 12 months, 18 months, 24 months

    Objectively measured physical activity will be recorded at each time point.

  3. Change in Nutritional Intake

    Time frame: Baseline, 12 months, 24 months

    Measured by 24-hour food recall

  4. Change in Psychosocial Status

    Time frame: Baseline, 6 months, 12 months, 18 months, 24 months

Sponsors and collaborators

Lead sponsor

Drexel University

Other

Registry information

Acronym: ENACT

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
May 21, 2013
Registry last updated
Aug 5, 2016

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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