ObesityLEANNCT01142206
The Leisure-time Activity and Nutrition Program
A study testing Dietary, Physical Activity and TV Watching + Physical Activity in people with Obesity, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Dietary, Physical Activity and TV Watching + Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthy Eating and Activity Laboratory
Knoxville, Tennessee, 37996
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Dietary, Physical Activity, TV Watching + Physical Activity
- Keywords
- Obesity, Weight Loss, Leisure-time activities, Physical Activity, Television watching, Dietary Intake, Energy, Behavioral, Healthy Eating
- Medical subject headings
- Obesity, Weight Loss, Motor Activity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietaryBehavioural
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 ActivityBehavioural
All participants will receive a physical activity goal of 200 minutes/week of moderate-intense physical activity.
TV Watching + Physical ActivityBehavioural
The TV Watching + physical activity arm will receive a TV watching goal of watching less than 10 hours of TV/week.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Dietary; Behavioral: 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. Receives: Behavioral: Dietary; Behavioral: Physical Activity; Behavioral: TV Watching + Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 9
Secondary outcomes (3)
Liking of physical activity and TV watching
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."
Measured: Week 9
Motivation for physical activity
Motivation for physical activity willbe measured via severl previously validated questionnaires.
Measured: Week 9
Dietary Intake (calories and % calories from fat) during TV watching or computer use
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.
Measured: Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hollie Raynor, The University of Tennessee, Knoxville
- Investigators
- Hollie A Raynor, PhD, RD, LDN, Principal investigator, University of TennesseeDavid Bassett Jr., PhD, Study chair, University of TennesseeDixie Thompson, PhD, Study chair, University of TennesseeAmy Gorin, PhD, Study chair, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142206
- Sponsor's protocol ID
- 7521B
- Acronym
- LEAN
- Status last verified
- Apr 2018
- First submitted
- 9 Jun 2010
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Two Different Leisure-time Activity Prescriptions on Eating and Activity Behaviors During Behavioral Weight Loss Treatment
- ClinicalTrials.gov ID
- NCT01142206
- Acronym / sponsor ID
- LEAN / 7521B
- Conditions
- Obesity
- Keywords
- Obesity, Weight Loss, Leisure-time activities, Physical Activity, Television watching, Dietary Intake, Energy, Behavioral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 11 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity | Active comparator | Behavioral: Dietary, Behavioral: Physical ActivityA standard behavioral weight loss intervention with a physical activity prescription of 200 minutes of moderate intensity physical activity per week. |
| Physical Activity & TV Watching | Experimental | Behavioral: Dietary, Behavioral: Physical Activity, Behavioral: TV Watching + Physical ActivityA 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietaryAll 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). | Behavioural | Physical Activity, Physical Activity & TV Watching |
| Physical ActivityAll participants will receive a physical activity goal of 200 minutes/week of moderate-intense physical activity. | Behavioural | Physical Activity, Physical Activity & TV Watching |
| TV Watching + Physical ActivityThe TV Watching + physical activity arm will receive a TV watching goal of watching less than 10 hours of TV/week. | Behavioural | Physical Activity & TV Watching |
Primary outcome
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.
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.
3 secondary outcomes
Liking of physical activity and TV watching
Time frame: Week 9
Motivation for physical activity
Time frame: Week 9
Dietary Intake (calories and % calories from fat) during TV watching or computer use
Time frame: Week 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- This is the website for the Healthy Eating and Activity Laboratory (HEAL), where this program is being conducted.)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hollie A Raynor, PhD, RD, LDN principal investigator
University of Tennessee
David Bassett Jr., PhD study chair
University of Tennessee
Dixie Thompson, PhD study chair
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary, Physical Activity and TV Watching + Physical Activity in people with Obesity, run by The University of Tennessee, Knoxville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent in moderate-intensity physical activity (time frame: Week 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.