Foundations for Health

Not Applicable

Completed

• Conditions: Overweight; Obese
• Interventions: Behavioral: Decrease Energy Density of the Diet; Behavioral: Increase Steps per Day; Behavioral: Consumption of Self-made Meals

• Registration Number: NCT01304615
• Lead Sponsor: The University of Tennessee, Knoxville

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-16
• Study First Submitted QC: 2011-02-24
• Study First Posted: 2011-02-25
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Web-Based	Decrease Energy Density of the Diet	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.
Web-Based	Increase Steps per Day	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.
Web-Based plus Culinary Training	Increase Steps per Day	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.
Web-Based plus Culinary Training	Decrease Energy Density of the Diet	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.
Web-Based plus Culinary Training	Consumption of Self-made Meals	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.

Primary Outcome Measures

Name	Time	Method
Energy Density (ED) of the Diet	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	3 months
consumption of Self-made Meals	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.

Secondary Outcome Measures

Name	Time	Method
Steps per Day	3 months	Measured using the Omron HJ 720 ITC pedometer.
Waist Circumference	3 months
Percent Body fat	3 months

Trial Locations

Locations (1)

University of Tennessee; 🇺🇸 Knoxville, Tennessee, United States