Using the Energy Gap to Prevent Weight Regain | NCT00429650

Studies
Using the Energy Gap to Prevent Weight Regain

NCT00429650

Sponsor

University of Colorado, Denver

Status

Completed

Last Update Posted

Jun 28, 2019Actual

Enrollment

175Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

increased exercise
diet
Exercise and Diet

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

ID	Type	Description	Link
R01DK071692	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Jan 30, 2007

First Submission Date that Met QC Criteria

Jan 31, 2007

First Posted Date

Feb 1, 2007Estimated

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

Jun 26, 2019

Last Update Posted Date

Jun 28, 2019Actual

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The major challenge in obesity treatment is not producing weight loss but in preventing that weight from being regained. There are many different methods to lose weight, but there are no recommendations for how you can best achieve long-term weight loss maintenance. Despite the method used to reduce one's body weight, very few of these individuals are able to keep their weight off permanently. This project aims to identify how much activity is necessary to prevent weight regain after weight loss.

Detailed Description

Not provided

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

175Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Increased amount of exercise to maintain weight loss.	Behavioral: increased exercise
2	Experimental	Combination of Exercise and Diet to maintain weight loss	Behavioral: Exercise and Diet
3	Active Comparator	Use diet alone to maintain weight loss.	Behavioral: diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
increased exercise	Behavioral	Use prescribed number of minutes of exercise 5-6 days per week to maintain weight loss.	1

Measure	Description	Time Frame
Change in Weight		18 Months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All ethnic groups and both genders
Age: Lower age limit: 19 years; Upper age limit: 45 years
Body-mass Index: Lower BMI limit: 30 kg/m2; Upper BMI limit: 40 kg/m2 and weight stable within +/- 5 pounds in the last 6 months, and currently at maximum non pregnant body weight (+/- 5%)
A negative treadmill stress test or subsequent follow up cardiac testing for cardiac ischemia.

Exclusion Criteria:

History of cardiovascular disease, including coronary artery disease, congestive heart failure, & unstable angina, or uncontrolled hypertension ( > 140/90 mm Hg)
Currently smoking or stopped smoking in the last 12 months
Medications affecting weight, energy intake, or energy expenditure in the last 6 months
Use of oral steroids within the last 12 months
History of stroke or seizures, thyroid disease, type 1 or 2 diabetes, Cushings syndrome, cerebrovascular, renal disease, hepatic disease, arrhythmias
Cancer requiring treatment in the past 5 years, with the exception of skin cancers other than melanoma
Infectious diseases: Self-reported HIV positivity or Active tuberculosis
Weight loss or weight gain of > 5% in past 6 months for any reason except post-partum weight loss
Likely to move away in next 1.5 years
Inability to adhere to the program such as inability to increase walking
Currently pregnant, lactating or less than 6 months post-partum
Major psychiatric disorder: Exclusions related to medications -Antipsychotic agents (these include, but are not limited to: Haldol, Loxitane, Mellaril, Navane, Prolixin, Stelazine, Thorazine, and Trilafon)
Current depression by history or Beck Depression Inventory (BDI)
Currently being treated for psychological condition

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Holly R. Wyatt, MD	University of Colorado at Denver Health Sciences Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Center for Human Nutrition		Denver	Colorado	80262	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24363955	Derived	Polsky S, Garratt Ogden L, Scown Maclean P, Danielle Giles E, Brill C, Roxanna Wyatt H. Biomarker Profile Does Not Predict Weight Loss Success in Successful and Unsuccessful Diet-Reduced Obese Individuals: a Prospective Study. ISRN Obes. 2013 Jan 1;2013:804129. doi: 10.1155/2013/804129.

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

ID	Term
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D009043	Motor Activity

ID	Term
D009765	Obesity
D015431	Weight Loss