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Foundations for Health (FFH)

Primary Purpose

Overweight, Obese

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decrease Energy Density of the Diet
Increase Steps per Day
Consumption of Self-made Meals
Sponsored by
The University of Tennessee, Knoxville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Overweight, Obesity, Young Adults, Energy Density, Culinary Skills, Physical Activity, Consumption of Self-made Meals, Family History of diabetes

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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:

  • 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.

Sites / Locations

  • University of Tennessee

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Web-Based

Web-Based plus Culinary Training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Body Weight
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.

Secondary Outcome Measures

Waist Circumference
Steps per Day
Measured using the Omron HJ 720 ITC pedometer.
Percent Body fat

Full Information

First Posted
February 16, 2011
Last Updated
April 3, 2018
Sponsor
The University of Tennessee, Knoxville
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1. Study Identification

Unique Protocol Identification Number
NCT01304615
Brief Title
Foundations for Health
Acronym
FFH
Official Title
Foundations for Health: Combining Culinary Skills Training With a Lifestyle Intervention in Young Overweight Adults at Risk for Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Tennessee, Knoxville

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obese
Keywords
Overweight, Obesity, Young Adults, Energy Density, Culinary Skills, Physical Activity, Consumption of Self-made Meals, Family History of diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Web-Based
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Web-Based plus Culinary Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Decrease Energy Density of the Diet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Increase Steps per Day
Intervention Description
Participants will increase their steps per day by at least 3,000 steps per day above their baseline levels.
Intervention Type
Behavioral
Intervention Name(s)
Consumption of Self-made Meals
Intervention Description
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.
Primary Outcome Measure Information:
Title
Energy Density (ED) of the Diet
Description
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
Title
Body Weight
Time Frame
3 months
Title
consumption of Self-made Meals
Description
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 Outcome Measure Information:
Title
Waist Circumference
Time Frame
3 months
Title
Steps per Day
Description
Measured using the Omron HJ 720 ITC pedometer.
Time Frame
3 months
Title
Percent Body fat
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hollie A. Raynor, Ph.D.
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carol Costello, Ph.D.
Organizational Affiliation
University of Tennessee
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ann Fairhurst, Ph.D.
Organizational Affiliation
University of Tennessee
Official's Role
Study Chair
Facility Information:
Facility Name
University of Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37996-1920
Country
United States

12. IPD Sharing Statement

Links:
URL
http://heal.utk.edu/
Description
This is the website for the Healthy Eating and Activity Laboratory (HEAL), where this program is being conducted.

Learn more about this trial

Foundations for Health

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