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Improving Weight Loss Maintenance Through Alternative Schedules of Treatment (ImWeL)

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Completed

Conditions

Obesity

Treatments

Behavioral: variable interval schedule
Behavioral: self-directed treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT02487121
K23DK081607 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment

108 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

108 participants in 2 patient groups

variable interval schedule
Experimental group
Description:
12 group-based extended care treatment sessions scheduled in 3, 4-week periods over a 12-month period
Treatment:
Behavioral: variable interval schedule
self-directed treatment
Active Comparator group
Description:
provision of treatment materials with instruction to work through materials at participant's own pace
Treatment:
Behavioral: self-directed treatment

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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