Clinical trial NCT01304615: Foundations for Health
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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obese
Keywords: Overweight
Obesity
Young Adults
Energy Density
Culinary Skills
Physical Activity
Consumption of Self-made Meals
Family History of diabetes
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Energy Density (ED) of the Diet
timeFrame: 3 months
measure: Body Weight
timeFrame: 3 months
measure: consumption of Self-made Meals
timeFrame: 3 months
Secondary outcomes:
measure: Waist Circumference
timeFrame: 3 months
measure: Steps per Day
timeFrame: 3 months
measure: Percent Body fat
timeFrame: 3 months
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Hollie A. Raynor, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tennessee
name: Carol Costello, Ph.D.
role: STUDY_CHAIR
affiliation: University of Tennessee
name: Ann Fairhurst, Ph.D.
role: STUDY_CHAIR
References: