- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02938312
Journey to Better Health (JTBH)
Deep South Network for Cancer Control - Healthier Weight Among African American Women
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Using a cluster-randomized study design, 400 overweight or obese African American women living in 8 rural counties in Alabama and Mississippi associated with the Deep South Network for Cancer Control will be assigned to either a weight loss only or weight loss plus community strategies condition for 2 years.
Weight Loss Only condition: In year 1, participants will attend weekly in-person group sessions (1.5 hours each) aimed at behavioral changes for weight loss (diet and physical activity) for 6 months followed by twice a month meetings for 3 months, then monthly meetings for 3 months. In year 2, monthly phone calls will be used to encourage continued behavior change or weight maintenance. In-person group meetings will be facilitated by a trained lay staff and community health advisors. Monthly phone calls will be conducted by the community health advisor.
Weight Loss Plus Community Strategies condition: Participants will receive the same weight loss program as the Weight Loss Only condition. In addition, a community-based organization or other non-profit group in the targeted community will receive funds and technical assistance to implement community-wide efforts to increase access to healthy affordable food and safe and convenient opportunities for physical activity (e.g., increase farmer's markets, develop walking trails).
Over the course of the study, participants will complete four full assessments to include measurement of height and weight (to calculate BMI), waist circumference, blood pressure, finger-stick blood draw for lipid and glucose testing, dietary recall, and questionnaires concerning participation in physical activity, self-efficacy for eating and exercise behaviors, depressive symptoms, perceived stress, social support, and demographic information (e.g., age, marital status, education, employment, household income).
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Alabama
-
Birmingham, Alabama, Verenigde Staten, 35294
- University of Alabama at Birmingham
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- African American female
- Live or work in target county
- BMI >= 25 kg/m2
Exclusion Criteria:
- Pregnant or planning to become pregnant in the next year
- Known major medical or psychological condition known to influence body weight
- Uncontrolled hypertension (BP > 160 mmHg systolic or >100 mmHg diastolic)
- Cardiovascular event in the preceding 12 months
- History of gastric bypass surgery
- History of psychiatric hospitalization in past 2 years
- History of substance abuse or eating disorder
- Any other condition by which a medical professional has suggested diet modification
- Physical activity and/or weight reduction would be contraindicated
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Actieve vergelijker: Weight Loss Only
24- month weight loss program (year 1: weekly in-person meetings for 6 months, followed by 2 meetings per month for 3 months, then monthly for 3 months; year 2: monthly phone calls)
|
Participants will attend in-person weekly sessions (about 1.5 hours each) for 6 months and then twice a month for 3 months and monthly for 3 months.
Sessions focus on behavioral techniques supporting healthy diet (including calorie restriction for weight loss) and achieving recommended amounts of physical activity per week.
During 1-year weight loss maintenance, participants receive monthly motivational phone calls.
|
Experimenteel: Weight Loss Plus
Same intervention as "Weight Loss Only" but includes community-wide interventions to increase access to healthy affordable food and opportunities for safe and convenient physical activity
|
Participants attend in-person meetings as described above.
This condition also includes community-wide strategies to increase access to healthy affordable food and safe opportunities for physical activity.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Weight
Tijdsspanne: baseline to 6-months
|
Measured weight (nearest kg)
|
baseline to 6-months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Waist Circumference
Tijdsspanne: baseline to 6-months
|
Measured circumference (nearest cm)
|
baseline to 6-months
|
Blood Pressure
Tijdsspanne: baseline to 6-months
|
Measured blood pressure (mmHG) - systolic and diastolic
|
baseline to 6-months
|
Lipids
Tijdsspanne: baseline to 6-months
|
Measured lipids - total cholesterol (mg/dL), Triglycerides (mg/dL), HDL, LDL, ratio
|
baseline to 6-months
|
Weight
Tijdsspanne: baseline to 12-months
|
Measured weight (nearest kg)
|
baseline to 12-months
|
Weight
Tijdsspanne: baseline to 24-months
|
Measured weight (nearest kg)
|
baseline to 24-months
|
Social Support for Healthy Eating and Exercise
Tijdsspanne: baseline to 6-months
|
Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise.
Composite and subscale scores are calculated.
|
baseline to 6-months
|
Social Support for Healthy Eating and Exercise
Tijdsspanne: baseline to 12-months
|
Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise.
Composite and subscale scores are calculated.
|
baseline to 12-months
|
Social Support Healthy Eating and Exercise
Tijdsspanne: baseline to 24-months
|
Self-report questionnaire about perceived level of family and friend support for healthy eating and exercise.
Composite and subscale scores are calculated.
|
baseline to 24-months
|
Self Efficacy for Healthy Eating and Exercise
Tijdsspanne: baseline to 6-months
|
Self-report questionnaire about confidence in ability to eat healthy and exercise.
Composite and subscale scores are calculated.
|
baseline to 6-months
|
Self Efficacy for Healthy Eating and Exercise
Tijdsspanne: baseline to 12-months
|
Self-report
|
baseline to 12-months
|
Self Efficacy for Healthy Eating and Exercise
Tijdsspanne: baseline to 24-months
|
Self-report questionnaire about confidence in ability to eat healthy and exercise.
Composite and subscale scores are calculated.
|
baseline to 24-months
|
Dietary Intake
Tijdsspanne: baseline to 6-months
|
24 hour recall
|
baseline to 6-months
|
Dietary Intake
Tijdsspanne: baseline to 12-months
|
24 hour recall
|
baseline to 12-months
|
Dietary Intake
Tijdsspanne: baseline to 24-months
|
24 hour recall
|
baseline to 24-months
|
Perceived Stress Scale
Tijdsspanne: baseline to 6-months
|
Self-report questionnaire about frequency of select stressful events.
Composite score is calculated based on responses.
|
baseline to 6-months
|
Perceived Stress Scale
Tijdsspanne: baseline to 12-months
|
Self-report questionnaire about frequency of select stressful events.
Composite score is calculated based on responses.
|
baseline to 12-months
|
Perceived Stress Scale
Tijdsspanne: baseline to 24-months
|
Self-report questionnaire about frequency of select stressful events.
Composite score is calculated based on responses.
|
baseline to 24-months
|
Medewerkers en onderzoekers
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- F100708003
- 1U54CA153719 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Gewichtsverlies
-
Vanderbilt University Medical CenterVoltooidLos vervolgtelefoongesprekken opVerenigde Staten
-
University of SheffieldMid Yorkshire Hospitals NHS TrustIngetrokkenObesitas, Acceptance and Commitment Therapy, Weight Management ServiceVerenigd Koninkrijk
-
Jose Soberon, MDVoltooidVerrekking van spieren en/of pezen van het onderbeen | Breuk van onderbeen | Verpletterende verwonding van het onderbeen | Volledige scheur, enkel- en/of voetband | Pathologische breuk - enkel en/of voet | Los lichaam in gewricht van enkel en/of voet | Fracture Malunion - Ankle and/ or FootVerenigde Staten
-
Ochsner Health SystemOnbekendVerrekking van spieren en/of pezen van het onderbeen | Breuk van onderbeen | Verpletterende verwonding van het onderbeen | Fractuur Malunion - enkel en/of voet | Aandoening van enkelgewricht en/of voet | Volledige scheur, enkel- en/of voetband | Pathologische breuk - enkel en/of voet | Los lichaam...Verenigde Staten
Klinische onderzoeken op Weight Loss Only
-
The Miriam HospitalVoltooidObesitas | OvergewichtVerenigde Staten
-
Consumer Wellness SolutionsVoltooid
-
Azienda Ospedaliera Universitaria Integrata VeronaOnbekendPostoperatieve complicaties | Postoperatieve pijn | Alvleesklierkanker | Hemodynamische instabiliteitItalië
-
Dartmouth-Hitchcock Medical CenterHitchcock FoundationVoltooidDepressie | ObesitasVerenigde Staten
-
Boston Medical CenterUniversity of Rhode IslandVoltooid
-
University of MinnesotaVoltooidObesitas | KindVerenigde Staten
-
University of AlbertaCanadian Institutes of Health Research (CIHR); Alberta Health services; Alberta...Voltooid
-
University of ConnecticutWeight Watchers InternationalVoltooidOvergewicht en obesitas
-
Indiana UniversityIndiana Clinical and Translational Sciences Institute; Weight Watchers International en andere medewerkersVoltooidObesitas | Prediabetes | Zwangerschapsdiabetes mellitusVerenigde Staten
-
Tel-Aviv Sourasky Medical CenterVoltooidOnvruchtbaarheid | Vaginaal bloedverliesIsraël