Study Stopped
Strict study protocol and lack of participant reimbursement was not advantageous and feasible as evidenced by the high rate of attrition.
Effects of a Weight Loss Intervention in College-age Women
1 other identifier
interventional
4
1 country
1
Brief Summary
Determine the effects of an 8-week weight loss intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2016
CompletedFirst Posted
Study publicly available on registry
November 17, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedJuly 26, 2018
July 1, 2018
6 months
November 9, 2016
July 24, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Body weight
18 months
Study Arms (2)
Counseling
EXPERIMENTALReceive counseling for 8-wks
Control
PLACEBO COMPARATORDoes not receive counseling for 8-wks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas Christian University
Fort Worth, Texas, 76102, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 9, 2016
First Posted
November 17, 2016
Study Start
January 1, 2017
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
July 26, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share