NCT00429650

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

January 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

June 28, 2019

Status Verified

June 1, 2019

Enrollment Period

6.5 years

First QC Date

January 30, 2007

Last Update Submit

June 26, 2019

Conditions

Obesity

Keywords

Weight maintenanceWeight loss

Outcome Measures

Primary Outcomes (1)

  • Change in Weight

    18 Months

Study Arms (3)

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

increased exerciseBEHAVIORAL

Use prescribed number of minutes of exercise 5-6 days per week to maintain weight loss.

1
dietBEHAVIORAL

Use a prescribed diet to maintain weight loss

3
Exercise and DietBEHAVIORAL

Use a combination of exercise and diet to maintain weight loss.

2

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Current depression by history or Beck Depression Inventory (BDI)
  • Currently being treated for psychological condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Human Nutrition

Denver, Colorado, 80262, United States

Location

Related Publications (1)

  • 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.

    PMID: 24363955DERIVED

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

DietExercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Holly R. Wyatt, MD

    University of Colorado at Denver Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2007

First Posted

February 1, 2007

Study Start

July 1, 2007

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

June 28, 2019

Record last verified: 2019-06

Locations

US(1)