NCT01142206

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 30 adults receiving an 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
28

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jun 2010

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

4 months

First QC Date

June 9, 2010

Last Update Submit

April 3, 2018

Conditions

Keywords

ObesityWeight LossLeisure-time activitiesPhysical ActivityTelevision watchingDietary IntakeEnergyBehavioralHealthy Eating

Outcome Measures

Primary Outcomes (2)

  • Time spent in moderate-intensity physical activity

    Participants will be given a closed motion sensor (Omron HJ-720 ITC Pocket Pedometers) to wear over the course of the program to measure number of steps and time spent engaged in moderate -intensity and higher physical activity. Days in which the sensor has been worn at least 10 hours only will be counted towards the seven days. The motion sensors will be downloaded onto computers at the baseline assessments and at week 9. During weeks 0 and 9 all participants will also keep a record of the self-reported physical activity.

    Week 9

  • Television watching time

    TV monitoring devices ("TV Allowances") will be hooked onto participants' home TVs by research staff. The devices will record the number of hours per week of TV the research participant is watching. Participants will also be asked to keep a record of their self-reported TV watching at 0 and 9 weeks.

    Week 9

Secondary Outcomes (3)

  • Liking of physical activity and TV watching

    Week 9

  • Motivation for physical activity

    Week 9

  • Dietary Intake (calories and % calories from fat) during TV watching or computer use

    Week 9

Study Arms (2)

Physical Activity

ACTIVE COMPARATOR

A standard behavioral weight loss intervention with a physical activity prescription of 200 minutes of moderate intensity physical activity per week.

Behavioral: DietaryBehavioral: Physical Activity

Physical Activity & TV Watching

EXPERIMENTAL

A standard behavioral weight loss intervention with a physical activity prescription of 200 minutes of moderate intensity physical activity per week and an additional prescription of reducing TV watching to 10 hours per week or less.

Behavioral: DietaryBehavioral: Physical ActivityBehavioral: TV Watching + Physical Activity

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).

Physical ActivityPhysical Activity & TV Watching

All participants will receive a physical activity goal of 200 minutes/week of moderate-intense physical activity.

Physical ActivityPhysical Activity & TV Watching

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

Physical Activity & TV Watching

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 45 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:

  • Report 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.
  • Report being unable to walk for 2 blocks (1/4 mile) without stopping.
  • Report 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)
  • Are unwilling to have TV Allowances attached to TVs in the home.
  • Report other household members are unwilling to use the TV Allowance.
  • Report major psychiatric diseases or organic brain syndromes via a phone screen.
  • Are currently participating in a weight loss program and/or taking weight loss medication or lost \> 5% of body weight during the past 6 months.
  • Are currently participating in a program to increase physical activity and/or decrease TV watching time.
  • Intend to move to another city within the time frame of the investigation.
  • Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation.
  • Have had gastric surgery for weight loss.
  • Are unwilling to attend weekly sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthy Eating and Activity Laboratory

Knoxville, Tennessee, 37996, United States

Location

Related Links

MeSH Terms

Conditions

ObesityWeight LossMotor ActivityBehavior

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, PhD, RD, LDN

    University of Tennessee

    PRINCIPAL INVESTIGATOR
  • David Bassett Jr., PhD

    University of Tennessee

    STUDY CHAIR
  • Dixie Thompson, PhD

    University of Tennessee

    STUDY CHAIR
  • Amy Gorin, PhD

    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

June 9, 2010

First Posted

June 11, 2010

Study Start

June 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations