OverweightNCT00989170
Family Program for Weight Gain Prevention
A study testing Family Program for the Prevention of Weight Gain in people with Overweight and Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The long-term goal of this project is to develop, evaluate, and disseminate to Extension Service families across the state of Colorado, an engaging, interactive, and evidence-based Family Program in order to prevent weight gain in adults and excess weight gain in children. Read more about this study
- Who is it for?
- Ages 3 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Family Program for the Prevention of Weight Gain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Dec 2012
- 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 3 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Families with at least one overweight child (8-12 years of age, BMI for age between the 84.6th and 95.4th percentile)
Who cannot join
- Individuals with physical or medical limitations that prevent them from engaging in physical activity. We will screen potential subjects and exclude subjects with an underlying disease that would inhibit activity using the Physical Activity Readiness Questionnaire (PAR-Q)
- Individuals using medication that influences body weight and appetite such as ADHD medication (e.g. Ritalin) and medication for depression.
- Pregnant and lactating women because their patterns of physical activity and eating may be different from their usual baseline. In the event a woman becomes pregnant during the study her data will not be included in the final analyses.
- Adults or children who are weight unstable due to weight loss surgery, weight loss medication, or dietary behavior.
- Families who do not have access to the internet at home or are not willing or able to use public access computers e.g., libraries and schools.
Trial locations and contacts
1 site in 1 country.
About this study
The long-term goal of this project is to develop, evaluate, and disseminate to Extension Service families across the state of Colorado, an engaging, interactive, and evidence-based Family Program in order to prevent weight gain in adults and excess weight gain in children. Excess weight gain in children is defined as an increase in body weight beyond the increase in weight associated with normal growth and development. The program will focus on small, easily adopted, sustainable, lifestyle changes.
Project Objectives include:
Read more
- Enhancing a Family Program by including food and physical activity environmental assessments, an online social network, and a pre-programmed health-based text messaging system, and by gaining feedback from extension families through a series of 6 focus groups.
- Conducting a randomized trial to evaluate the impact of the enhanced Family Program on the prevention of weight gain in families with overweight children. The investigators hypothesize that excess weight gain will be prevented in subjects in the intervention group, while those in the control group will gain excess weight.
- Disseminating the Family Program through USDA Cooperative Extension Services in Colorado and evaluate the usefulness/effectiveness of the program for USDA Extension agents and participating families. The investigators will conduct 4 additional focus groups at the end of this objective to gain feedback on its usefulness in a "real-life" setting. This objective is different from objective 2 in that the investigators are evaluating the program in a real-life setting, using qualitative and self-reported data, rather than conducting a clinical trial.
By conducting focus groups with Extension families during both objectives #1 and 3, the Family Program will help to improve knowledge regarding behavioral and environmental factors influencing obesity. After enhancing the Family Program (Objective #1), the investigators will test its effectiveness in a randomized study of 200 families (Objective #2). Finally, after having developed and tested this effective intervention strategy, the investigators will disseminate it through Extension Agents throughout the state to evaluate its usefulness in a "real-life" setting (Objective #3).
- Conditions
- Overweight, Obesity
- Being tested
- Family Program for the Prevention of Weight Gain, Control Group
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Program for the Prevention of Weight GainBehavioural
The Family Workbook is a step-by-step instruction guide for families to use throughout the 6-month period, detailing healthy lifestyle. All handouts, instructions, activities, and a timeline of the program are laid out for families in this workbook.
Control GroupBehavioural
This group will not be provided the workbook and it is hypothesized those in the control group will gain excess weight.
| Study group | Role | What they receive |
|---|---|---|
| Family Program for the Prevention of Weight Gain | Experimental | Use of an enhanced Family Program on the prevention of weight gain in families with overweight children. Receives: Behavioral: Family Program for the Prevention of Weight Gain |
| No enhanced Family Program | Active comparator | Not described Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of the randomized study is the proportion of overweight children who gain BMIp during the 6-month study period.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Sponsor
- Investigators
- James Hill, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989170
- Sponsor's protocol ID
- 08-1206
- Status last verified
- Feb 2016
- First submitted
- 1 Oct 2009
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Program for Weight Gain Prevention
- ClinicalTrials.gov ID
- NCT00989170
- Acronym / sponsor ID
- 08-1206
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- Jul 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Oct 2009 (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 long-term goal of this project is to develop, evaluate, and disseminate to Extension Service families across the state of Colorado, an engaging, interactive, and evidence-based Family Program in order to prevent weight gain in adults and excess weight gain in children. Excess weight gain in children is defined as an increase in body weight beyond the increase in weight associated with normal growth and development. The program will focus on small, easily adopted, sustainable, lifestyle changes.
Project Objectives include:
- Enhancing a Family Program by including food and physical activity environmental assessments, an online social network, and a pre-programmed health-based text messaging system, and by gaining feedback from extension families through a series of 6 focus groups.
- Conducting a randomized trial to evaluate the impact of the enhanced Family Program on the prevention of weight gain in families with overweight children. The investigators hypothesize that excess weight gain will be prevented in subjects in the intervention group, while those in the control group will gain excess weight.
- Disseminating the Family Program through USDA Cooperative Extension Services in Colorado and evaluate the usefulness/effectiveness of the program for USDA Extension agents and participating families. The investigators will conduct 4 additional focus groups at the end of this objective to gain feedback on its usefulness in a "real-life" setting. This objective is different from objective 2 in that the investigators are evaluating the program in a real-life setting, using qualitative and self-reported data, rather than conducting a clinical trial.
By conducting focus groups with Extension families during both objectives #1 and 3, the Family Program will help to improve knowledge regarding behavioral and environmental factors influencing obesity. After enhancing the Family Program (Objective #1), the investigators will test its effectiveness in a randomized study of 200 families (Objective #2). Finally, after having developed and tested this effective intervention strategy, the investigators will disseminate it through Extension Agents throughout the state to evaluate its usefulness in a "real-life" setting (Objective #3).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Program for the Prevention of Weight Gain | Experimental | Behavioral: Family Program for the Prevention of Weight GainUse of an enhanced Family Program on the prevention of weight gain in families with overweight children. |
| No enhanced Family Program | Active comparator | Behavioral: Control Group |
Who may qualify
- Ages
- 3 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Families with at least one overweight child (8-12 years of age, BMI for age between the 84.6th and 95.4th percentile)
Key exclusion criteria (5 listed)
- Individuals with physical or medical limitations that prevent them from engaging in physical activity. We will screen potential subjects and exclude subjects with an underlying disease that would inhibit activity using the Physical Activity Readiness Questionnaire (PAR-Q)
- Individuals using medication that influences body weight and appetite such as ADHD medication (e.g. Ritalin) and medication for depression.
- Pregnant and lactating women because their patterns of physical activity and eating may be different from their usual baseline. In the event a woman becomes pregnant during the study her data will not be included in the final analyses.
- Adults or children who are weight unstable due to weight loss surgery, weight loss medication, or dietary behavior.
- Families who do not have access to the internet at home or are not willing or able to use public access computers e.g., libraries and schools.
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 |
|---|---|---|
| Family Program for the Prevention of Weight GainThe Family Workbook is a step-by-step instruction guide for families to use throughout the 6-month period, detailing healthy lifestyle. All handouts, instructions, activities, and a timeline of the program are laid out for families in this workbook. | Behavioural | Family Program for the Prevention of Weight Gain |
| Control GroupThis group will not be provided the workbook and it is hypothesized those in the control group will gain excess weight. | Behavioural | No enhanced Family Program |
Primary outcome
The primary outcome of the randomized study is the proportion of overweight children who gain BMIp during the 6-month study period.
Time frame: 6 months
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 10 Feb 2016.
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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.
James Hill, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Program for the Prevention of Weight Gain in people with Overweight and Obesity, run by University of Colorado, Denver 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 1 inclusion and 5 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 10 Feb 2016. 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?
The primary outcome of the randomized study is the proportion of overweight children who gain BMIp during the 6-month study period. (time frame: 6 months). 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 10 Feb 2016.