Community-based Obesity Treatment in African American Women After Childbirth
2022년 7월 6일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
300
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19140
- Temple University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
여성
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Usual care (UC)
Usual postpartum WIC care
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Weight loss (kilograms)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Obesogenic dietary behaviors
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Utilize Reach Effectiveness Adoption Implementation (RE-AIM) to evaluate the intervention's dissemination potential
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Sharon J Herring, MD MPH, Temple University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 9월 1일
기본 완료 (실제)
2021년 1월 1일
연구 완료 (실제)
2021년 6월 1일
연구 등록 날짜
최초 제출
2016년 1월 28일
QC 기준을 충족하는 최초 제출
2016년 7월 7일
처음 게시됨 (추정)
2016년 7월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 7월 7일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 7월 6일
마지막으로 확인됨
2022년 7월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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.
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .