- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01304615
Foundations for Health (FFH)
3. april 2018 oppdatert av: Hollie Raynor, The University of Tennessee, Knoxville
Foundations for Health: Combining Culinary Skills Training With a Lifestyle Intervention in Young Overweight Adults at Risk for Type 2 Diabetes
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.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
10
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Tennessee
-
Knoxville, Tennessee, Forente stater, 37996-1920
- University of Tennessee
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 35 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
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.
Participants will increase their steps per day by at least 3,000 steps per day above their baseline levels.
|
|
Eksperimentell: 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.
|
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.
Participants will increase their steps per day by at least 3,000 steps per day above their baseline levels.
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Energy Density (ED) of the Diet
Tidsramme: 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.
|
3 months
|
|
Body Weight
Tidsramme: 3 months
|
3 months
|
|
|
consumption of Self-made Meals
Tidsramme: 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.
|
3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Midjeomkrets
Tidsramme: 3 måneder
|
3 måneder
|
|
|
Steps per Day
Tidsramme: 3 months
|
Measured using the Omron HJ 720 ITC pedometer.
|
3 months
|
|
Percent Body fat
Tidsramme: 3 months
|
3 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Hollie A. Raynor, Ph.D., University of Tennessee
- Studiestol: Carol Costello, Ph.D., University of Tennessee
- Studiestol: Ann Fairhurst, Ph.D., University of Tennessee
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2011
Primær fullføring (Faktiske)
1. desember 2011
Studiet fullført (Faktiske)
1. desember 2011
Datoer for studieregistrering
Først innsendt
16. februar 2011
Først innsendt som oppfylte QC-kriteriene
24. februar 2011
Først lagt ut (Anslag)
25. februar 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. april 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. april 2018
Sist bekreftet
1. april 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FFH E01-1703-011
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .