The Leisure-time Activity and Nutrition Program (LEAN)

April 3, 2018 updated by: Hollie Raynor, The University of Tennessee, Knoxville

The Effects of Two Different Leisure-time Activity Prescriptions on Eating and Activity Behaviors During Behavioral Weight Loss Treatment

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.

Study Overview

Detailed Description

In adult observational studies, TV viewing has been positively related to overweight and obesity. It is theorized that TV watching influences eating and activity behaviors, such that with greater TV watching less physical activity and greater consumption of energy occurs, producing a positive energy balance state. While no experimental research has been conducted with adults examining the influence of reducing TV watching on weight status, experimental research conducted with children does indicate that lower levels of TV watching can produce reduced energy intake and greater levels of physical activity. Most importantly, family-based, behavioral childhood obesity interventions that have targeted reducing sedentary behaviors (which includes TV watching) have found that as compared to targeting increasing physical activity during treatment, similar increases in activity and fitness occur, but that greater weight loss and greater increases in liking for physical activity occur when sedentary behaviors, as compared to physical activity, are targeted in family-based behavioral childhood weight control programs.

All participants in the investigation will receive a standard 8-week behavioral obesity intervention. The intervention will include a reduced caloric prescription (1200-1500 kcal/day) and fat gram prescription (30% or less kcals from fat). One condition will receive an activity goal (200 minutes/week of moderate-intense physical activity [Physical Activity]), while the other condition will receive a TV watching goal (10 hours/week) and a physical activity goal (200 minutes/week of moderate-intense physical activity [TV + Physical Activity]. Participants will be assessed at 0 and 9 weeks (pre- and post-intervention) on measures of dietary intake, physical activity, TV watching, time-use, motivation, liking of physical activity and TV watching, and weight.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tennessee
      • Knoxville, Tennessee, United States, 37996
        • Healthy Eating and Activity Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Physical Activity
A standard behavioral weight loss intervention with a physical activity prescription of 200 minutes of moderate intensity physical activity per week.
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).
All participants will receive a physical activity goal of 200 minutes/week of moderate-intense physical activity.
Experimental: Physical Activity & TV Watching
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.
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).
All participants will receive a physical activity goal of 200 minutes/week of moderate-intense physical activity.
The TV Watching + physical activity arm will receive a TV watching goal of watching less than 10 hours of TV/week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time spent in moderate-intensity physical activity
Time Frame: Week 9
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
Time Frame: Week 9
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liking of physical activity and TV watching
Time Frame: Week 9
Participants will rate the pleasantness of engaging in physical activity and TV watching using a 100 mm visual analogue scale (VAS), anchored on the left with "very unpleasant" and on the right by "very pleasant."
Week 9
Motivation for physical activity
Time Frame: Week 9
Motivation for physical activity willbe measured via severl previously validated questionnaires.
Week 9
Dietary Intake (calories and % calories from fat) during TV watching or computer use
Time Frame: Week 9
Dietary intake will be assessed by three-day food records at weeks 0 and 9. Along with recording foods and drink consumed, participants will indicate in the record when TV is being watched as food and drinks are consumed. These food records will be reviewed to ensure that information written about consumption is complete and incomplete dairies will be reviewed with participants. Dietary data will be analyzed using NDS-R software.
Week 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hollie A Raynor, PhD, RD, LDN, University of Tennessee
  • Study Chair: David Bassett Jr., PhD, University of Tennessee
  • Study Chair: Dixie Thompson, PhD, University of Tennessee
  • Study Chair: Amy Gorin, PhD, University of Connecticut

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

June 9, 2010

First Submitted That Met QC Criteria

June 9, 2010

First Posted (Estimate)

June 11, 2010

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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