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Effects of a Weight Loss Intervention in College-age Women

Primary Purpose

Weight Loss

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counseling
No Counseling
Sponsored by
Texas Christian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Texas Christian University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Counseling

Control

Arm Description

Receive counseling for 8-wks

Does not receive counseling for 8-wks

Outcomes

Primary Outcome Measures

Body weight

Secondary Outcome Measures

Full Information

First Posted
November 9, 2016
Last Updated
July 24, 2018
Sponsor
Texas Christian University
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1. Study Identification

Unique Protocol Identification Number
NCT02966431
Brief Title
Effects of a Weight Loss Intervention in College-age Women
Official Title
Effects of a Weight Loss Intervention in College-age Women
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Strict study protocol and lack of participant reimbursement was not advantageous and feasible as evidenced by the high rate of attrition.
Study Start Date
January 2017 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Christian University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Counseling
Arm Type
Experimental
Arm Description
Receive counseling for 8-wks
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Does not receive counseling for 8-wks
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Intervention Type
Behavioral
Intervention Name(s)
No Counseling
Primary Outcome Measure Information:
Title
Body weight
Time Frame
18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Texas Christian University
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76102
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of a Weight Loss Intervention in College-age Women

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