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OpenTrials
Completed

NCT Number: NCT02487121

Improving Weight Loss Maintenance Through Alternative Schedules of Treatment

This project examines the effects of differing schedules of extended care contact following weight loss treatment in order to prevent weight regain following treatment.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • At least 21 years-old
  • body mass index (BMI) = 28.0 - 45.0 kg/m2
  • willing to provide informed consent and accept randomization

Exclusion criteria

  • BMI >45 kg/m2
  • Illnesses requiring medical attention and/or conditions for which weight loss and moderate physical activity would be inadvisable: diabetes not under active treatment, myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; congestive heart failure; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); serious infectious diseases (e.g., self-reported HIV); chronic hepatitis; cirrhosis; chronic malabsorption syndrome; chronic pancreatitis; chronic lung diseases that limit physical activity; orthopedic injuries or conditions that significantly limit physical activity.
  • Conditions or behaviors likely to affect the conduct of the trial: unwilling or unable to give informed consent; unable to read English at the 5th grade level; unwilling to accept random assignment; unwilling or unable to travel to attend intervention (due to distance from clinic, work schedule or other scheduling conflicts); likely to relocate out of the service area in next 18 months.

Treatment and study plan

variable interval schedule

Behavioral

12 group-based extended care treatment sessions scheduled in 3, 4-week periods over a 12-month period

self-directed treatment

Behavioral

provision of treatment materials with instruction to work through materials at participant's own pace

Primary outcomes

  1. body weight (kg)

    Time frame: 12 months

    change in body weight (kg) between randomization and month-12 follow-up

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Acronym: ImWeL

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jul 1, 2015
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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