- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02219763
The Effects of a Weight Management Program on Body Weight and Quality of Life
A Longitudinal Study to Investigate the Effects of a 14-visit Comprehensive Lifestyle Weight Management Program on Body Weight and Quality of Life
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
This study will evaluate weight change and quality of life among individuals after completion of a 12-week comprehensive group weight management program. Findings from this study will also help with program development and improvement within our center. The already established weight management program is called Healthy Habits for Life (HHL) and includes a total of 14 visits (one individual visit both before and after the 12 group sessions).
All patients who are enrolled in the Healthy Habits for Life group program at the Weight Center have an individual visit with a registered dietitian prior to beginning the group as part of standard care. At this visit the dietitian will obtain informed consent for participation in the research study and provide subjects consenting to participate in the study with the IWQOL-lite quality of life questionnaire.
After completion of the 12 HHL group sessions, all patients at the Weight Center have another individual visit with the dietitian to review weight and behavior changes since the initial evaluation. At this visit, subjects participating in the research study will again be provided with the IWQOL-lite questionnaire to fill out.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Rekruttering
- MGH Weight Center, Massachusetts General Hospital
-
Ledende efterforsker:
- Sonja S Goedkoop, MSPH, RD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- English speaking adults aged 18 or older
- BMI ≥ 25
- Enrolled in HHL program at the MGH Weight Center
Exclusion Criteria:
- Non-English speaking patients
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Weight Change
Tidsramme: Approximately 4 months after enrollment
|
The primary outcomes will be change in body weight comparing body weight at the start of the behavior change program and at the end.
This includes weight at the initial individual visit, weights at each of the 12 group visits and body weight at the end of the group program.
|
Approximately 4 months after enrollment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Quality of Life
Tidsramme: Approximately 4 months after enrollment
|
Quality of life will be assessed with a validated questionnaire at the start of the group and after completion of the group program.
|
Approximately 4 months after enrollment
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Blood laboratory values
Tidsramme: Approximately 4 months after enrollment
|
Labs collected include: Albumin, Alkaline Phosphatase, Total Bilirubin, Total Protein, ALT, AST, HbA1C, Lipids and Insulin.
These labs will be collected at a patients first visit to the Weight Center and again after completion of the group program.
|
Approximately 4 months after enrollment
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Sonja S Goedkoop, MSPH, RD, Massachusetts General Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2014P001032
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