Foundations for Health (FFH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hollie Raynor, University of Tennessee
ClinicalTrials.gov Identifier:
NCT01304615
First received: February 16, 2011
Last updated: November 14, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Overweight
Obese
Behavioral: Decrease Energy Density of the Diet
Behavioral: Increase Steps per Day
Behavioral: Consumption of Self-made Meals

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Foundations for Health: Combining Culinary Skills Training With a Lifestyle Intervention in Young Overweight Adults at Risk for Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Energy Density (ED) of the Diet [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • consumption of Self-made Meals [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Steps per Day [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Measured using the Omron HJ 720 ITC pedometer.

  • Percent Body fat [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: February 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
Behavioral: Increase Steps per Day
Participants will increase their steps per day by at least 3,000 steps per day above their baseline levels.
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
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.
Behavioral: Increase Steps per Day
Participants will increase their steps per day by at least 3,000 steps per day above their baseline levels.
Behavioral: Consumption 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304615

Locations
United States, Tennessee
University of Tennessee
Knoxville, Tennessee, United States, 37996-1920
Sponsors and Collaborators
University of Tennessee
Investigators
Principal Investigator: Hollie A. Raynor, Ph.D. University of Tennessee
Study Chair: Carol Costello, Ph.D. University of Tennessee
Study Chair: Ann Fairhurst, Ph.D. University of Tennessee
  More Information

Additional Information:
No publications provided

Responsible Party: Hollie Raynor, Assocaite Professor, University of Tennessee
ClinicalTrials.gov Identifier: NCT01304615     History of Changes
Other Study ID Numbers: FFH E01-1703-011
Study First Received: February 16, 2011
Last Updated: November 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee:
Overweight
Obesity
Young Adults
Energy Density
Culinary Skills
Physical Activity
Consumption of Self-made Meals
Family History of diabetes

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014