Foundations for Health

NCT01304615 | Completed

• 1 other identifier: FFH E01-1703-011
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obese

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  3 months

• Body Weight

  3 months

• 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.

  3 months

Secondary Outcomes (3)

• Waist Circumference

  3 months

• Steps per Day

  3 months

• Percent Body fat

  3 months

Study Arms (2)

Web-Based

ACTIVE COMPARATOR

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

Web-Based plus Culinary Training

EXPERIMENTAL

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

Decrease Energy Density of the Diet BEHAVIORAL

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.

Web-Based; Web-Based plus Culinary Training

Increase Steps per Day BEHAVIORAL

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

Web-Based; Web-Based plus Culinary Training

Consumption of Self-made Meals BEHAVIORAL

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.

Web-Based plus Culinary Training

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead

Study Sites (1)

University of Tennessee

Knoxville, Tennessee, 37996-1920, United States

Location

Related Links

• This is the website for the Healthy Eating and Activity Laboratory (HEAL), where this program is being conducted.

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Hollie A. Raynor, Ph.D.

  University of Tennessee

  PRINCIPAL INVESTIGATOR

• Carol Costello, Ph.D.

  University of Tennessee

  STUDY CHAIR

• Ann Fairhurst, Ph.D.

  University of Tennessee

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: February 25, 2011
• Study Start: February 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

US (1)