Effects of a Weight Loss Intervention in College-age Women

Not Applicable

Terminated

• Conditions: Weight Loss
• Interventions: Behavioral: No Counseling; Behavioral: Counseling

• Registration Number: NCT02966431
• Lead Sponsor: Texas Christian University

Brief Summary

Determine the effects of an 8-week weight loss intervention.

Detailed Description

The purpose of this study is three-fold: 1) Determine whether an 8-week, patient-centered, weight loss intervention can be successfully implemented in overweight, college-age females for promotion of weight loss and prevention of weight regain at 8-weeks, three months, and six months follow-up; 2) Determine the effects of the intervention on established markers of calorie restriction, energy expenditure and body composition; 3) Determine the effects of a liquid meal on physiological and subjective markers of hunger and satiety from pre- to post- 8wk intervention in the intervention group vs control group.

Study Timeline

• Study First Submitted: 2016-11-09
• Study First Submitted QC: 2016-11-15
• Study First Posted: 2016-11-17
• Study Start: 2017-01
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-24
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

Inclusion Criteria

• Females age 18-25years
• Body Mass Index 25.0 to 29.9 kg/m2 (overweight)
• Agree to receive frequent contacts from investigators and communicate with program staff for up to 6 months
• Willing to measure blood glucose via finger prick test three to eight times per day for two weeks
• Able to give written informed consent
• Able to comply with study procedures

Exclusion Criteria

• Unable or unwilling to give informed consent
• Travel plans that do not permit participation
• Pregnant or planning on becoming pregnant during the 6 months of participation in the study
• Weight loss or gain exceeding 5% of body weight in the past 3 months
• Current participation in a weight loss program
• Diagnosis of mental disorder or chronic disease
• History of eating disorder such as anorexia nervosa, bulimia nervosa, or binge eating disorder (unless approved by program staff)
• History of surgery or procedure that could affect swallowing or digestion
• Any person who is on a medically prescribed diet
• Any current supplement use other than a daily multivitamin
• Any current metabolic medication use other than birth control
• Any bleeding disorders or blood clotting problems
• Anyone who has donated blood or plasma in the last 20 days
• Any tobacco or illicit drug users
• Anyone who has allergies to any of the components of the liquid meal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	No Counseling	Does not receive counseling for 8-wks
Counseling	Counseling	Receive counseling for 8-wks

Primary Outcome Measures

Name	Time	Method
Body weight	18 months

Trial Locations

Locations (1)

Texas Christian University; 🇺🇸 Fort Worth, Texas, United States