NCT00065338

Brief Summary

These studies will provide us with enormous insight regarding how obese patients adapt energetically during negative energy balance. We will gain fundamental information regarding the metabolic implications of combining food restriction with a walking program compatible to that advocated by statutory agencies. These studies will lead to improved understanding of the energetic adaptation that occurs during negative energy balance and how best to treat patients with obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for phase_1 obesity

Timeline
Completed

Started Jun 2003

Longer than P75 for phase_1 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

Study Start

First participant enrolled

June 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2003

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

April 5, 2011

Status Verified

April 1, 2011

Enrollment Period

4.4 years

First QC Date

July 21, 2003

Last Update Submit

April 1, 2011

Conditions

Obesity

Keywords

Physical activity

Outcome Measures

Primary Outcomes (1)

  • Non Exercise Activity Thermogenesis

    Weeks 2 and 11, each period

Secondary Outcomes (2)

  • Body weight

    Daily

  • Body Composition

    Weeks 2 and 11, each period

Interventions

Exercise and behavior modificationBEHAVIORAL

Participants will undergo 1000 kcal/day caloric restriction (relative to experimentally determined weight-maintenance caloric needs) for 8 weeks during one phase of study. Additional 11 week period consists of 8 weeks of caloric restriction with an additional daily walking program.

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Ninety sedentary subjects, aged 25-55, who live \<10 miles from Rochester will be recruited. This age range has been selected to enable us to study individuals at the peak age-range of obesity and over-weight prevalence and to avoid issues of menopause. Subjects will not be eligible for consideration if they take two or more bouts of exercise/week or participate in sports for more than 2 hours/week. Subjects with predicted weight maintenance energy requirements of \<2000 kcal/day will have been excluded at screening. This is because when we come to underfeeding by 1000 kcal/day, we want to avoid feeding any volunteer \<1000 kcal/day, for safety \& compliance reasons. (A) LEAN: 30 (15F,15M) lean subjects; BMI \<25 kg/m2. Each lean subject will be individually matched for height (+3cm) and age (+3 years) to an obese subject so as to establish comparable groupings for body size. Subjects will have been weight-stable for six months (B) OBESE: 30 (15F,15M) obese subjects; BMI 30-35 kg/m2. Subjects will have been weight-stable for six months (C) POST-OBESE: 30 (15F,15M) patients will have had a previous BMI \>30 kg/m2 and a weight loss sufficient to achieve a BMI of \<26 kg/m2 maintained for at least 2 months (with weight fluctuation during this period of \<1 kg) (94). We will attempt to match these subjects to the obese subjects as described above.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Levine JA, Lanningham-Foster LM, McCrady SK, Krizan AC, Olson LR, Kane PH, Jensen MD, Clark MM. Interindividual variation in posture allocation: possible role in human obesity. Science. 2005 Jan 28;307(5709):584-6. doi: 10.1126/science.1106561.

    PMID: 15681386RESULT

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

ExerciseBehavior Therapy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • James A Levine, M.D., Ph.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2003

First Posted

July 23, 2003

Study Start

June 1, 2003

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

April 5, 2011

Record last verified: 2011-04

Locations

US(1)