Effects of a Weight Loss Intervention in College-age Women

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

Study Overview

• Status: Terminated
• Conditions: Weight Loss
• Intervention / Treatment: Behavioral: Counseling; Behavioral: No Counseling

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76102
      • Texas Christian University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Body weight	18 months

Collaborators and Investigators

• Sponsor: Texas Christian University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: November 9, 2016
• First Submitted That Met QC Criteria: November 15, 2016
• First Posted (Estimate): November 17, 2016

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: CT2016JS2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO