NCT00656045

Brief Summary

The purpose of this investigation is to conduct an 8-week pilot study to examine the effects of two different leisure-time activity prescriptions on dietary intake, leisure-time activities, and weight loss in 26 adults receiving a standard 8-week behavioral weight loss intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2008

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

4 months

First QC Date

April 4, 2008

Last Update Submit

April 3, 2018

Conditions

ObesityPhysical Activity

Keywords

ObesityPhysical ActivityWeight LossExerciseDietary IntakeEnergyBehavioralHealthy Eating

Outcome Measures

Primary Outcomes (1)

  • Time spent in moderate-intense physical activity

    8 weeks

Secondary Outcomes (4)

  • Weight loss

    8 weeks

  • Caloric and fat intake while watching TV

    8 weeks

  • Liking of physical activity

    8 weeks

  • Time spent watching TV

    8 weeks

Study Arms (2)

A

EXPERIMENTAL

Arm A focuses on increasing the participant's physical activity level.

Behavioral: DietaryBehavioral: Physical Activity

B

EXPERIMENTAL

Arm B focuses on decreasing the amount of time the participant spends watching Television.

Behavioral: DietaryBehavioral: TV Watching

Interventions

DietaryBEHAVIORAL

All participants in the investigation will receive a standard 8-week behavioral obesity intervention with 8 weekly, 1 hour group counseling and education sessions. The intervention will include a reduced caloric prescription (1200-1500 kcal/day) and fat gram prescription (30% or less kcals from fat).

AB
Physical ActivityBEHAVIORAL

The Physical Activity arm will receive an activity goal (200 minutes/week of moderate-intense physical activity).

A
TV WatchingBEHAVIORAL

The TV Watching arm will receive a TV watching goal of watching less than 10 hours of TV/week.

B

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index (BMI) between 25 and 40 kg/m2
  • Watch \> 16 hours per week of TV
  • Engage in \< 100 minutes of moderate-intense physical activity per week

You may not qualify if:

  • Participants reporting a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Individuals self-reporting joint problems, prescription medication usage related to heart conditions, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
  • Reporting they are unable to walk for 2 blocks (1/4 mile) without stopping.
  • Reporting no TVs in the home or 5 or more TVs in the home viewed by the participant (TVs in participant's children's bedrooms will not be counted).
  • Reporting major psychiatric diseases or organic brain syndromes via a phone screen.
  • Participating in a weight loss program and/or taking weight loss medication or that have lost \> 5% of body weight during the past 6 months.
  • Participating in a program to increase physical activity and/or decrease TV watching time.
  • Intending to move to another city within the time frame of the investigation.
  • Being pregnant, lactating, less than 6 months post-partum, or planning to become pregnant during the time frame of the investigation.
  • Having had gastric surgery for weight loss.
  • Being unwilling to attend weekly sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

Related Links

MeSH Terms

Conditions

ObesityMotor ActivityWeight LossBehavior

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

  • Hollie A. Raynor, Ph.D.

    University of Tennessee

    PRINCIPAL INVESTIGATOR

  • David Bassett Jr., Ph.D.

    University of Tennessee

    STUDY CHAIR

  • Dixie Thompson, Ph.D.

    University of Tennessee

    STUDY CHAIR

  • Amy Gorin, Ph.D.

    University of Connecticut

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 4, 2008

First Posted

April 10, 2008

Study Start

March 1, 2008

Primary Completion

July 1, 2008

Study Completion

September 1, 2008

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations

US(1)