Effects of a Weight Loss Intervention in College-age Women

Study Overview
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Brief Summary
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Determine the effects of an 8-week weight loss intervention.

Detailed Description
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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.

Official Title
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Effects of a Weight Loss Intervention in College-age Women

Conditions
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Weight Loss

Intervention / Treatment
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* Behavioral: Counseling
* Behavioral: No Counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Counseling<br>Receive counseling for 8-wks | Behavioral: Counseling<br> <br> |
| Placebo Comparator: Control<br>Does not receive counseling for 8-wks | Behavioral: No Counseling<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | 18 months |