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CompletedNCT01304615FFHUpdated Apr 5, 2018

Foundations for Health

An interventional study of Decrease Energy Density of the Diet and Increase Steps per Day in Overweight and Obese, sponsored by The University of Tennessee, Knoxville. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-05.

Sponsored by The University of Tennessee, Knoxville · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Overweight
  • Obese

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Keywords

  • Overweight
  • Obesity
  • Young Adults
  • Energy Density
  • Culinary Skills
  • Physical Activity
  • Consumption of Self-made Meals
  • Family History of diabetes
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 850 are open to participants now.

This study's enrollment of 10 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

The University of Tennessee, Knoxville is the lead sponsor of 95 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

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).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.
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
10 participants (actual)

Study arms

  • Active comparator
    Web-Based

    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.

    Behavioral: Decrease Energy Density of the Diet · Behavioral: Increase Steps per Day

  • Experimental
    Web-Based plus Culinary Training

    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.

    Behavioral: Decrease Energy Density of the Diet · Behavioral: Increase Steps per Day · Behavioral: Consumption of Self-made Meals

Interventions

  • BehavioralDecrease Energy Density of the Diet

    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.

  • BehavioralIncrease Steps per Day

    Participants will increase their steps per day by at least 3,000 steps per day above their baseline levels.

  • BehavioralConsumption of Self-made Meals

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

  2. Body Weight

    Time frame: 3 months

  3. 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.

    Time frame: 3 months

Secondary outcomes

  1. Waist Circumference

    Time frame: 3 months

  2. Steps per Day

    Measured using the Omron HJ 720 ITC pedometer.

    Time frame: 3 months

  3. Percent Body fat

    Time frame: 3 months

07

Study locations

1 site
  • University of Tennessee
    Knoxville, Tennessee 37996-1920, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01304615
Lead sponsor
The University of Tennessee, Knoxville
Responsible party
Hollie Raynor (Professor, The University of Tennessee, Knoxville) — Principal investigator
First posted
Feb 25, 2011
Start date
Feb 2011
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Apr 5, 2018

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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