Leisure Time Activity and Nutrition Program (LEAN)

This study has been completed.
Sponsor:
Information provided by:
University of Tennessee
ClinicalTrials.gov Identifier:
NCT00656045
First received: April 4, 2008
Last updated: September 26, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention
Obesity
Physical Activity
Behavioral: Dietary
Behavioral: Physical Activity
Behavioral: TV Watching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Two Different Leisure-Time Activity Prescriptions on Eating and Activity Behaviors During Behavioral Weight Loss Treatment

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Time spent in moderate-intense physical activity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight loss [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Caloric and fat intake while watching TV [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Liking of physical activity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Time spent watching TV [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: March 2008
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Arm A focuses on increasing the participant's physical activity level.
Behavioral: Dietary
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).
Behavioral: Physical Activity
The Physical Activity arm will receive an activity goal (200 minutes/week of moderate-intense physical activity).
Experimental: B
Arm B focuses on decreasing the amount of time the participant spends watching Television.
Behavioral: Dietary
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).
Behavioral: TV Watching
The TV Watching arm will receive a TV watching goal of watching less than 10 hours of TV/week.

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.

Thus, this investigation will involve an 8-week pilot study to examine the effects of two different leisure-time activity prescriptions. 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 [ TV Watching]). Participants will be assessed at 0 and 9 weeks (pre- and post-intervention) on measures of dietary intake, physical activity, TV watching, liking of physical activity and TV watching, and weight.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656045

Locations
United States, Tennessee
University of Tennessee
Knoxville, Tennessee, United States, 37996
Sponsors and Collaborators
University of Tennessee
Investigators
Principal Investigator: Hollie A. Raynor, Ph.D. University of Tennessee
Study Chair: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Hollie Raynor, Ph.D., R.D., University of Tennessee
ClinicalTrials.gov Identifier: NCT00656045     History of Changes
Other Study ID Numbers: LEAN E01-1703-011
Study First Received: April 4, 2008
Last Updated: September 26, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee:
Obesity
Physical Activity
Weight Loss
Exercise
Dietary Intake
Energy
Behavioral
Healthy Eating

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 25, 2014