OverweightFFHNCT01304615
Foundations for Health
A study testing Decrease Energy Density of the Diet, Increase Steps per Day and Consumption of Self-made Meals in people with Overweight and Obese, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
Foundations for Health is a 12-week behavioral weight loss interventions primarily conducted via the internet aimed at helping overweight and obese young adults (ages 18-30) lose weight by increasing physical activity, decreasing the energy density of the diet, and increasing consumption of low energy dense self-made… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obese
- What is being tested?
- Decrease Energy Density of the Diet, Increase Steps per Day and Consumption of Self-made Meals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Dec 2011
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 35 years old.
- BMI between 25 and 45 kg/m2.
- Have type 2 diabetes or an adult family member, first or second degree relative, with type 2 diabetes.
- Have a cooking and food preparation area, along with cooking utensils, available in their current living situation.
- Consume > 3 restaurant/fast food meals/week.
- Regular and reliable internet access via a computer.
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).20
- Report not being able to walk for two blocks.
- Report major psychiatric diseases or organic brain syndromes.
- 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.
- Intend to have bariatric surgery within the time frame of the investigation.
- Intend to move outside of the metropolitan area within the time frame of the investigation.
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- Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation.
- Have percent body fat < 20% for females or < 13% for males.
- Live with an adult who is responsible for food purchasing and/or meal preparation.
- Have purchased a full meal plan from a college dining services program.
- Do not have regular access to transportation (needed for food purchases).
- Do not provide email contact information that is needed for access to web- based program.
- Report consuming > 10 self-made lunches or dinners per week.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee
Knoxville, Tennessee, 37996-1920
About this study
Official title: Foundations for Health: Combining Culinary Skills Training With a Lifestyle Intervention in Young Overweight Adults at Risk for Type 2 Diabetes
Foundations for Health is a 12-week behavioral weight loss interventions primarily conducted via the internet aimed at helping overweight and obese young adults (ages 18-30) lose weight by increasing physical activity, decreasing the energy density of the diet, and increasing consumption of low energy dense self-made meals by providing culinary training skills.
Read the detailed description
Young adulthood is recognized as a key time to focus on health promotion/disease prevention, as this time is when young individuals begin to transition to independence and thus are adopting health behaviors that will be carried into later adulthood. Unfortunately, this time period is often marked by decreases in physical activity and dietary quality. Working with young adults as they establish their first independent living situation can help set the foundation for behaviors that may aid with lifelong weight management and chronic disease prevention. Foundations for Health is the first study to examine the effect of a web-based lifestyle modification program in combination with culinary skills or lifestyle skills training sessions on weight loss, dietary intake, and meal preparation behaviors using a reduced energy dense diet in young adults with a family history of diabetes. Foundations for Health will provide a 12-week weight loss intervention for overweight and obese young adults, aged 18 to 35 years. Study participants will be randomly assigned to one of two conditions: 1) a web-based behavioral intervention that decreases dietary energy density and increases physical activity; and 2) the same intervention combined with a hands-on culinary skills training program designed to increase food purchasing and meal self-preparation and consumption of meals low in energy density. The primary aims of this feasibility study are: 1) determine if the web-based plus culinary training condition has a greater increase in food purchasing, meal preparation/cooking behaviors, and intake of self-made meals; and a greater decrease in consumption of "convenience meals" than the web-based condition at 3 months; and 2) determine if the web-based plus culinary training condition has a greater decrease in dietary energy density and percent energy from fat and a greater increase in fruit and vegetable consumption than the web-based condition at 3 months.
- Conditions
- Overweight, Obese
- Being tested
- Decrease Energy Density of the Diet, Increase Steps per Day, Consumption of Self-made Meals
- Keywords
- Overweight, Obesity, Young Adults, Energy Density, Culinary Skills, Physical Activity, Consumption of Self-made Meals, Family History of diabetes
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decrease Energy Density of the DietBehavioural
Participants will be given goals to help guide their food choices to decrease the energy density of the overall diet. The goals are to eat 10 or more foods with an ED less than 1.0 and 2 or less foods with an ED of great than 3.0 each day and to reduce portion sizes.
Increase Steps per DayBehavioural
Participants will increase their steps per day by at least 3,000 steps per day above their baseline levels.
Consumption of Self-made MealsBehavioural
Participants will have the goal of increasing the number of self-prepared meals that they consume to 10 or more lunch and dinner meals each week.
| Study group | Role | What they receive |
|---|---|---|
| Web-Based | Active comparator | Participants will receive a web-based behavioral intervention that decreases dietary energy density and increases physical activity combined with a life skills training program. Life skills training topics include stress management, coping with change, time management, and thoughts and emotions in weight control. Receives: Behavioral: Decrease Energy Density of the Diet; Behavioral: Increase Steps per Day |
| Web-Based plus Culinary Training | Experimental | Participants will receive a web-based behavioral intervention that decreases dietary energy density and increases physical activity combined with a hands-on culinary skills training program designed to increase food purchasing and meal self-preparation and consumption of meals low in energy density. Receives: Behavioral: Decrease Energy Density of the Diet; Behavioral: Increase Steps per Day; Behavioral: Consumption of Self-made Meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy Density (ED) of the Diet
ED of the diet is will be collected using a 3 day food record and calcuated by determining the mean of the total kcals/gram weight of food consumed for each day.
Measured: 3 months
Body Weight
Measured: 3 months
consumption of Self-made Meals
In a 3 day food record participants will report all if each meal was self-prepared, with self-prepared being defined as is a meal/food made by you that uses fruits, vegetables, low-fat sauces or herbs, lean meats, or meatless options as the main dish (entrée) of the meal. The main dish would be the component of the meal that you feel is making the largest contribution to the meal.
Measured: 3 months
Secondary outcomes (3)
Waist Circumference
Measured: 3 months
Steps per Day
Measured using the Omron HJ 720 ITC pedometer.
Measured: 3 months
Percent Body fat
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2011
- Study completionDec 2011
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.
- 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
- 10 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, Ph.D., Principal investigator, University of TennesseeCarol Costello, Ph.D., Study chair, University of TennesseeAnn Fairhurst, Ph.D., Study chair, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304615
- Sponsor's protocol ID
- FFH E01-1703-011
- Acronym
- FFH
- Status last verified
- Apr 2018
- First submitted
- 16 Feb 2011
- 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
- Foundations for Health: Combining Culinary Skills Training With a Lifestyle Intervention in Young Overweight Adults at Risk for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01304615
- Acronym / sponsor ID
- FFH / FFH E01-1703-011
- Conditions
- Overweight, Obese
- Keywords
- Overweight, Obesity, Young Adults, Energy Density, Culinary Skills, Physical Activity, Consumption of Self-made Meals, Family History of diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Feb 2011 (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.
Foundations for Health is a 12-week behavioral weight loss interventions primarily conducted via the internet aimed at helping overweight and obese young adults (ages 18-30) lose weight by increasing physical activity, decreasing the energy density of the diet, and increasing consumption of low energy dense self-made meals by providing culinary training skills.
Detailed description
Young adulthood is recognized as a key time to focus on health promotion/disease prevention, as this time is when young individuals begin to transition to independence and thus are adopting health behaviors that will be carried into later adulthood. Unfortunately, this time period is often marked by decreases in physical activity and dietary quality. Working with young adults as they establish their first independent living situation can help set the foundation for behaviors that may aid with lifelong weight management and chronic disease prevention. Foundations for Health is the first study to examine the effect of a web-based lifestyle modification program in combination with culinary skills or lifestyle skills training sessions on weight loss, dietary intake, and meal preparation behaviors using a reduced energy dense diet in young adults with a family history of diabetes. Foundations for Health will provide a 12-week weight loss intervention for overweight and obese young adults, aged 18 to 35 years. Study participants will be randomly assigned to one of two conditions: 1) a web-based behavioral intervention that decreases dietary energy density and increases physical activity; and 2) the same intervention combined with a hands-on culinary skills training program designed to increase food purchasing and meal self-preparation and consumption of meals low in energy density. The primary aims of this feasibility study are: 1) determine if the web-based plus culinary training condition has a greater increase in food purchasing, meal preparation/cooking behaviors, and intake of self-made meals; and a greater decrease in consumption of "convenience meals" than the web-based condition at 3 months; and 2) determine if the web-based plus culinary training condition has a greater decrease in dietary energy density and percent energy from fat and a greater increase in fruit and vegetable consumption than the web-based condition at 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-Based | Active comparator | Behavioral: Decrease Energy Density of the Diet, Behavioral: Increase Steps per DayParticipants will receive a web-based behavioral intervention that decreases dietary energy density and increases physical activity combined with a life skills training program. Life skills training topics include stress management, coping with change, time management, and thoughts and emotions in weight control. |
| Web-Based plus Culinary Training | Experimental | Behavioral: Decrease Energy Density of the Diet, Behavioral: Increase Steps per Day, Behavioral: Consumption of Self-made MealsParticipants will receive a web-based behavioral intervention that decreases dietary energy density and increases physical activity combined with a hands-on culinary skills training program designed to increase food purchasing and meal self-preparation and consumption of meals low in energy density. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18 and 35 years old.
- BMI between 25 and 45 kg/m2.
- Have type 2 diabetes or an adult family member, first or second degree relative, with type 2 diabetes.
- Have a cooking and food preparation area, along with cooking utensils, available in their current living situation.
- Consume > 3 restaurant/fast food meals/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).20
- Report not being able to walk for two blocks.
- Report major psychiatric diseases or organic brain syndromes.
- 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.
- Intend to have bariatric surgery within the time frame of the investigation.
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 |
|---|---|---|
| Decrease Energy Density of the DietParticipants will be given goals to help guide their food choices to decrease the energy density of the overall diet. The goals are to eat 10 or more foods with an ED less than 1.0 and 2 or less foods with an ED of great than 3.0 each day and to reduce portion sizes. | Behavioural | Web-Based, Web-Based plus Culinary Training |
| Increase Steps per DayParticipants will increase their steps per day by at least 3,000 steps per day above their baseline levels. | Behavioural | Web-Based, Web-Based plus Culinary Training |
| Consumption of Self-made MealsParticipants will have the goal of increasing the number of self-prepared meals that they consume to 10 or more lunch and dinner meals each week. | Behavioural | Web-Based plus Culinary Training |
Primary outcome
Energy Density (ED) of the Diet
Time frame: 3 months
ED of the diet is will be collected using a 3 day food record and calcuated by determining the mean of the total kcals/gram weight of food consumed for each day.
Body Weight
Time frame: 3 months
consumption of Self-made Meals
Time frame: 3 months
In a 3 day food record participants will report all if each meal was self-prepared, with self-prepared being defined as is a meal/food made by you that uses fruits, vegetables, low-fat sauces or herbs, lean meats, or meatless options as the main dish (entrée) of the meal. The main dish would be the component of the meal that you feel is making the largest contribution to the meal.
3 secondary outcomes
Waist Circumference
Time frame: 3 months
Steps per Day
Time frame: 3 months
Percent Body fat
Time frame: 3 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 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, Ph.D. principal investigator
University of Tennessee
Carol Costello, Ph.D. study chair
University of Tennessee
Ann Fairhurst, Ph.D. 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 Decrease Energy Density of the Diet, Increase Steps per Day and Consumption of Self-made Meals in people with Overweight and Obese, 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 6 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?
Energy Density (ED) of the Diet (time frame: 3 months). The study lists 3 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.