Effects of a Weight Loss Intervention in College-age Women

Weight Loss Clinical Trial

Official title:

Effects of a Weight Loss Intervention in College-age Women

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02966431
• Other study ID #: CT2016JS2
• Status: Terminated
• Phase: N/A
• Start date: January 2017
• Est. completion date: July 2017

Study information

• Verified date: July 2018
• Source: Texas Christian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

Behavioral:
• Counseling

• No Counseling

Locations

Country	Name	City	State
United States	Texas Christian University	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Christian University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight		18 months