- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00562263
Barriers to Effective Weight Loss in Overweight Adolescents (TEENS)
Barriers to Effective Weight Loss in Overweight Adolescents Enrolled in an Intensive, Team-based, Family-centered Lifestyle Modification Program
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The study will annually enroll 100 - 200 adolescent male and female subjects between 11 and 18 years of age with a BMI > the 85th percentile and one parent. Adolescents enrolled in the study, will participate in a structured exercise program and meet regularly with a dietitian and behavior specialist for nutrition education and review and update of progress and goals. The study is designed for 2 years of participation with data collection points at baseline, 3 months, 6 months, 1 year and 2 years. Data collected from adolescents include demographic information anthropometric information (height, weight, blood pressure, temperature, pulse, percent body fat); assessments of nutritional knowledge, food choices and dietary intake; assessments of activity and fitness level of behavioral status (depression, self-esteem, self-confidence, satisfaction with life, happiness, perspectives on health, exercise and diet, family environment, quality of life, body awareness, teasing, social efficacy, self-perception, coping mechanisms), assessments of sleep time and quality and physiological and medical data (including blood and urine tests)
Parents will accompany their children to the nutrition and behavior support visits, and attend 12 group educational sessions to learn skills and strategies to help their children adopt healthier eating and exercise behaviors. Data collected from parents will include demographic, anthropometric measures (height, weight, blood pressure, temperature, pulse, percent body fat); and assessments of activity level, dietary intake and eating habits, behavioral status, child-feeding practices, and understanding of their child.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Virginia
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Richmond, Virginia, Forenede Stater, 23298
- Virginia Commonwealth University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age between 11 and 18
- BMI at or above the 85th percentile for age and sex
- At least one adult in the household who is committed to come to the program meetings
Exclusion Criteria:
- Previous enrollment in VCU IRB 3354
- Underlying genetic, neurologic, endocrine, or metabolic conditions that preclude weight loss with conventional diet and exercise programs
- Weight greater than 400 pounds
- Pregnancy in female adolescent subjects
- Inability to understand program instructions due to language barrier or a mental disability
- Primary residence outside a 30 mile radius program facility.
- Primary participating parent, if female, cannot be pregnant during the period corresponding to the parents intervention.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Lifestyle Modification
Parents are randomized to attend 12 educational sessions covering strategies to manage children's health behaviors.
|
Dietary modification and regular physical activity
Andre navne:
|
Ingen indgriben: Control
Teen participates in lifestyle intervention, but parent does not attend parent education sessions
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
changes in BMI Z-score
Tidsramme: 3 month, 6 month, 12 months and 24 months
|
3 month, 6 month, 12 months and 24 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Changes in body composition, metabolic and anthropometric measures, fitness measures, dietary intake, and quality of life scores.
Tidsramme: 3 month, 6 month, 1 year and 2 years.
|
3 month, 6 month, 1 year and 2 years.
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Gary L. Francis, M.D., Virginia Commonwealth University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HM11113
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