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Journey to Better Health (JTBH)

21. oktober 2016 oppdatert av: Monica L Baskin, University of Alabama at Birmingham

Deep South Network for Cancer Control - Healthier Weight Among African American Women

This study is being conducted in 8 rural counties in Alabama and Mississippi (4 per state). Approximately 400 overweight or obese African American women living in the selected counties will participate in a 2-year weight loss study.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

409

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
        • University of Alabama at Birmingham

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

30 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Weight
Tidsramme: baseline to 6-months
Measured weight (nearest kg)
baseline to 6-months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Waist Circumference
Tidsramme: baseline to 6-months
Measured circumference (nearest cm)
baseline to 6-months
Blood Pressure
Tidsramme: baseline to 6-months
Measured blood pressure (mmHG) - systolic and diastolic
baseline to 6-months
Lipids
Tidsramme: baseline to 6-months
Measured lipids - total cholesterol (mg/dL), Triglycerides (mg/dL), HDL, LDL, ratio
baseline to 6-months
Weight
Tidsramme: baseline to 12-months
Measured weight (nearest kg)
baseline to 12-months
Weight
Tidsramme: baseline to 24-months
Measured weight (nearest kg)
baseline to 24-months
Social Support for Healthy Eating and Exercise
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: baseline to 12-months
Self-report
baseline to 12-months
Self Efficacy for Healthy Eating and Exercise
Tidsramme: 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
Tidsramme: baseline to 6-months
24 hour recall
baseline to 6-months
Dietary Intake
Tidsramme: baseline to 12-months
24 hour recall
baseline to 12-months
Dietary Intake
Tidsramme: baseline to 24-months
24 hour recall
baseline to 24-months
Perceived Stress Scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: baseline to 24-months
Self-report questionnaire about frequency of select stressful events. Composite score is calculated based on responses.
baseline to 24-months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

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. august 2010

Primær fullføring (Faktiske)

1. april 2015

Studiet fullført (Faktiske)

1. august 2015

Datoer for studieregistrering

Først innsendt

17. oktober 2016

Først innsendt som oppfylte QC-kriteriene

18. oktober 2016

Først lagt ut (Anslag)

19. oktober 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

24. oktober 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. oktober 2016

Sist bekreftet

1. oktober 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • F100708003
  • 1U54CA153719 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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