Effects of a Weight Loss Intervention in College-age Women

Texas Christian University

Status: Terminated

Conditions: Weight Loss

Treatments: Behavioral: No Counseling; Behavioral: Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT02966431

CT2016JS2

Details and patient eligibility

About

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

Full 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.

Enrollment: 4 patients

Sex: Female

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4 participants in 2 patient groups, including a placebo group

Counseling

Experimental group

Description:

Receive counseling for 8-wks

Treatment:

Behavioral: Counseling

Control

Placebo Comparator group

Description:

Does not receive counseling for 8-wks

Treatment:

Behavioral: No Counseling