Health TrialsbyHealthPanel

Weight Management Intervention in College: A Pilot

ConditionObesity and Overweight
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-29
SponsorThe Miriam Hospital

About this trial

This pilot randomized controlled trial will examine a behavioral weight loss intervention that uses a "small change" approach fro emerging adult college students with overweight/obesity. The primary aim is to assess student acceptability and clinically-meaningful weight changes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

BMI of 25 or greater

Enrolled at college/university where study will take place

English-speaking

Disqualifiers

History or current diagnosis of anorexia nervosa, bulimia nervosa, or alcohol use disorder (current symptoms also assessed at screening using validated screening questionnaires)

Participation in another formal weight loss program or current utilization of obesity medications

Current or recent pregnancy

Psychiatric hospitalization in the past 12 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • BWLI-College

    Behavioral

    Behavioral modifications are based on empirically-supported principles for weight loss. Diet recommendations follow a small change approach in which participants will make a series of small, self-selected dietary changes each day (\~100-200 calories) that they build on over the course of the intervention. Physical activity recommendations are to achieve 150-250 weekly minutes of moderate-to-vigorous physical activity with specific goals and rate of progression that are individualized to each participant.

  • Control

    Behavioral

    Psychoeducation around dieting myths, healthy eating, and physical activity

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: BWLI-CollegeExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Acceptability

Refers to the satisfactory nature of a treatment and will be assessed via the 4-item Acceptability of Intervention Measure. Benchmarks are to reach mean scores of at least 4 out of 5.

Time frame
10 weeks
2

Retention

Rate of retention of 70% or more (benchmark)

Time frame
10 weeks
3

Adherence

Average attendance of 75% or more (benchmark)

Time frame
10 weeks
4

Weight Loss

Average weight loss of at least 3%

Time frame
10 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Miriam Hospital

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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