- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02829229
Community-based Obesity Treatment in African American Women After Childbirth
6. juli 2022 opdateret af: Temple University
Community-based Obesity Treatment in African American Women After Childbirth: a Randomized Controlled Trial of Women Infant Children (WIC) Mothers
The purpose of this study is to determine the effect of the community-based obesity treatment (PP), compared to usual care (UC), on changes in maternal weight over 12 months.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The investigators propose to randomize overweight or obese, African American postpartum WIC participants (n=300) to either usual care (UC) or a community-based obesity treatment (PP) arm.
Recruitment will occur in 6 of Philadelphia Women Infants Children's (WIC) clinic sites in the early postpartum period (≤ 6 months after birth).
Once enrolled, participants will complete surveys and baseline assessments of their weight, waist circumference, blood pressure, and height at The Center for Obesity Research and Education (CORE).
Participants will also have a fasting blood sample taken.
Study staff will administer a number of questionnaires assessing demographics, psychosocial factors, contextual factors, and behavioral targets via questionnaires prior to randomization.
Participants will then be randomized to the 12-month postpartum weight loss intervention (PP) or usual care (UC).
Additional assessments will be conducted at 6 and 12 months post baseline.
The PP arm includes expanded obesogenic behavior change goals, tailored skills training materials, interactive self-monitoring text messages, video testimonials, and interpersonal counseling support through health coach calls and Facebook.
Data will be analyzed using an intent-to-treat (ITT) approach where subjects are analyzed according to their treatment assignment at randomization, regardless of level of engagement.
The primary outcome is weight loss at 12 months.
If successful, the expected results could provide a sustainable, low-cost, postpartum weight loss intervention model for widespread dissemination to reduce disparities in obesity and cardiometabolic comorbidities.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
300
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19140
- Temple University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Self-identification as African American
- Self-report pre-pregnancy BMI between 25-49.9 kg/m2
- Measured BMI at baseline between 25-49.9 kg/m2
- Philadelphia WIC participant
- Singleton birth
- Between 1 and 6 months postpartum
- Own a cell phone with an unlimited text messaging plan
- Able to participate in light physical activity (walking)
- Participants must be willing to comply with all study-related procedures
- Participants must be able to read and write fluently in English
Exclusion Criteria:
- BMI ≤ 24.9 or ≥ 50.0 kg/m2
- Uncontrolled hypertension (systolic blood pressure > 160 or diastolic blood pressure > 95 mmHg). Participants with controlled hypertension on medication for at least three months are allowable.
- Known atherosclerotic cardiovascular disease
- Known congestive heart failure
- Known diabetes mellitus (type 1 or type 2)
- Known thyroid disease
- Any major active rheumatologic, pulmonary, hepatic, dermatologic disease or inflammatory condition requiring steroids or immune modulating medications
- History of testing HIV positive
- Current smoker or tobacco user. Participants with < 5 cigarettes daily are allowable
- Current or recent history (past 6 months) of drug or alcohol abuse or dependence
- Participation in any weight control or investigational drug study within 6 weeks of screening
- Current consumption of any of the following medications: appetite suppressants, anti-psychotics, lipase inhibitors
- Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety for successful participation in the study
- Gastrointestinal Disorders (gallbladder disease, Crohn's disease, etc)
- Previous weight loss surgery
- History of bulimia or anorexia
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: Usual care (UC)
Usual postpartum WIC care
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Eksperimentel: Community-based obesity treatment (PP)
The PP arm includes expanded obesogenic behavior change goals, tailored skills training materials, interactive self-monitoring text messages, video testimonials, and interpersonal counseling support through health coach calls and Facebook.
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Participants in the treatment (PP) arm will receive a 5-component intervention: 1)Behavior change goals; 2)Self-monitoring; 3)Tailored skills training; 4)Video testimonials & 5)Interpersonal counseling.
Both treatment and usual care arms will receive the current standard of care offered to postpartum mothers at WIC.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Weight loss (kilograms)
Tidsramme: At baseline and 12 months
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Weight will be measured using a calibrated scale at baseline and 12-month follow-up.
Weight loss will be calculated as the difference between mean 12-month and baseline weight in kilograms.
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At baseline and 12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Obesogenic dietary behaviors
Tidsramme: At baseline and 12 months
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Using National Cancer Institute's Diet History Questionnaire, the investigators will assess categories of sugary drink intake, fast/fried food intake, and snacking at baseline and 12-month follow-up.
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At baseline and 12 months
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Insulin Resistance
Tidsramme: At baseline and 12 months
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Blood will be drawn to assess insulin resistance (insulin and glucose).
The Homeostatic model assessment for Insulin Resistance (HOMA-IR) calculation will be used to quantify participant mean insulin resistance at baseline and 12-month follow-up.
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At baseline and 12 months
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Health-related quality of life
Tidsramme: At baseline and 12 months
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Short Form-12 (SF-12) questionnaire will be used to collect health-related quality of life at baseline and 12-month follow-up.
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At baseline and 12 months
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Physical Activity
Tidsramme: At baseline and 12 months
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Wrist Actigraphy will be used to measure physical activity (average number of steps) at baseline and 12-month follow-up.
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At baseline and 12 months
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Physical Activity
Tidsramme: At baseline and 12 months
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Wrist Actigraphy will be used to measure physical activity (average intensity of activity) at baseline and 12-month follow-up.
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At baseline and 12 months
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Sleep
Tidsramme: At baseline and 12 months
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Wrist Actigraphy will be used to measure sleep (mean duration of sleep) at baseline and 12-month follow-up.
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At baseline and 12 months
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Sleep
Tidsramme: At baseline and 12 months
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Wrist Actigraphy will be used to measure sleep (mean sleep efficiency) at baseline and 12-month follow-up.
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At baseline and 12 months
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Sleep
Tidsramme: At baseline and 12 months
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Wrist Actigraphy will be used to measure sleep (mean wake after sleep onset) at baseline and 12-month follow-up.
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At baseline and 12 months
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Hemoglobin A1c (HbA1c)
Tidsramme: At baseline and 12 months
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Hemoglobin A1c test will be performed by a lab to identify the 3-month average plasma glucose concentration at baseline and 12-month follow-up.
The investigators will categorize participants as no diabetes (HbA1c <5.7), prediabetes (HBA1c 5.7-6.4), and diabetes (HBA1c >6.4) at both timepoints.
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At baseline and 12 months
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Lipids
Tidsramme: At baseline and 12 months
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Total cholesterol test will be performed by a lab to identify mean total blood cholesterol level, low density lipoprotein and high density lipoprotein levels at baseline and 12-month follow-up.
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At baseline and 12 months
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Utilize Reach Effectiveness Adoption Implementation (RE-AIM) to evaluate the intervention's dissemination potential
Tidsramme: 12 months
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The five steps are Reach the target population; Effectiveness; Adoption by target staff, settings or institutions; Implementation consistency, costs and adaptions made during delivery and Maintenance of intervention effects in individuals and settings over time.
Previously collected data such as target population characteristics; attrition and completion percentages; results related to primary, secondary and unintended outcomes; intervention fidelity; participant knowledge application and sustainability will be used within scope of 5 steps to determine dissemination potential.
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12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Sharon J Herring, MD MPH, Temple University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. september 2016
Primær færdiggørelse (Faktiske)
1. januar 2021
Studieafslutning (Faktiske)
1. juni 2021
Datoer for studieregistrering
Først indsendt
28. januar 2016
Først indsendt, der opfyldte QC-kriterier
7. juli 2016
Først opslået (Skøn)
12. juli 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. juli 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. juli 2022
Sidst verificeret
1. juli 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 23187
- R01HL130816 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Dr. Herring (PI) will ensure that all publications that result from data collected as part of this project will comply with the NIH public access policy.
Also, Dr. Herring agrees to develop a transportable de-identified database, codebook, and mechanism by which data can be shared with other investigators upon approval of the study's research team.
The Resource Sharing Plan will be reviewed and approved by Temple University's Institutional Review Board.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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The Miriam HospitalNational Heart, Lung, and Blood Institute (NHLBI)Rekruttering
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University of RochesterNational Institute of Mental Health (NIMH)AfsluttetPsykotiske lidelserForenede Stater
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Stanford UniversityAnonymous DonorRekrutteringAutismespektrumforstyrrelse | Autisme | ASDForenede Stater