Effects of a Weight Loss Intervention in College-age Women | NCT02966431

Studies
Effects of a Weight Loss Intervention in College-age Women

NCT02966431

Sponsor

Texas Christian University

Status

Terminated

Last Update Posted

Jul 26, 2018Actual

Enrollment

4Actual

Phase

Not Applicable

Conditions

Weight Loss

Interventions

Counseling
No Counseling

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Strict study protocol and lack of participant reimbursement was not advantageous and feasible as evidenced by the high rate of attrition.

Expanded Access Info

Start Date

Jan 2017Actual

Primary Completion Date

Jul 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

Nov 9, 2016

First Submission Date that Met QC Criteria

Nov 15, 2016

First Posted Date

Nov 17, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2018

Last Update Posted Date

Jul 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Counseling	Experimental	Receive counseling for 8-wks	Behavioral: Counseling
Control	Placebo Comparator	Does not receive counseling for 8-wks	Behavioral: No Counseling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Counseling	Behavioral		Counseling
No Counseling

Measure	Description	Time Frame
Body weight		18 months

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Texas Christian University		Fort Worth	Texas	76102	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D008605	Mental Health Services
D004191	Behavioral Disciplines and Activities
D003153	Community Health Services
D006296	Health Services