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Community-based Obesity Treatment in African American Women After Childbirth

Primary Purpose

Obesity, Overweight

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Community-based obesity treatment (PP)

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Temple University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care (UC)

Community-based obesity treatment (PP)

Arm Description

Usual postpartum WIC care

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.

Outcomes

Primary Outcome Measures

Weight loss (kilograms)

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.

Secondary Outcome Measures

Obesogenic dietary behaviors

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.

Insulin Resistance

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.

Health-related quality of life

Short Form-12 (SF-12) questionnaire will be used to collect health-related quality of life at baseline and 12-month follow-up.

Physical Activity

Wrist Actigraphy will be used to measure physical activity (average number of steps) at baseline and 12-month follow-up.

Physical Activity

Wrist Actigraphy will be used to measure physical activity (average intensity of activity) at baseline and 12-month follow-up.

Sleep

Wrist Actigraphy will be used to measure sleep (mean duration of sleep) at baseline and 12-month follow-up.

Sleep

Wrist Actigraphy will be used to measure sleep (mean sleep efficiency) at baseline and 12-month follow-up.

Sleep

Wrist Actigraphy will be used to measure sleep (mean wake after sleep onset) at baseline and 12-month follow-up.

Hemoglobin A1c (HbA1c)

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.

Lipids

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.

Full Information

NCT ID

NCT02829229

First Posted

January 28, 2016

Last Updated

July 6, 2022

Sponsor

Temple University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT02829229

Brief Title

Community-based Obesity Treatment in African American Women After Childbirth

Official Title

Community-based Obesity Treatment in African American Women After Childbirth: a Randomized Controlled Trial of Women Infant Children (WIC) Mothers

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

September 2016 (Actual)

Primary Completion Date

January 2021 (Actual)

Study Completion Date

June 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Temple University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Overweight

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual care (UC)

Arm Type

No Intervention

Arm Description

Usual postpartum WIC care

Arm Title

Community-based obesity treatment (PP)

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Community-based obesity treatment (PP)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Weight loss (kilograms)

Description

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.

Time Frame

At baseline and 12 months

Secondary Outcome Measure Information:

Title

Obesogenic dietary behaviors

Description

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.

Time Frame

At baseline and 12 months

Title

Insulin Resistance

Description

Time Frame

At baseline and 12 months

Title

Health-related quality of life

Description

Short Form-12 (SF-12) questionnaire will be used to collect health-related quality of life at baseline and 12-month follow-up.

Time Frame

At baseline and 12 months

Title

Physical Activity

Description

Wrist Actigraphy will be used to measure physical activity (average number of steps) at baseline and 12-month follow-up.

Time Frame

At baseline and 12 months

Title

Physical Activity

Description

Wrist Actigraphy will be used to measure physical activity (average intensity of activity) at baseline and 12-month follow-up.

Time Frame

At baseline and 12 months

Title

Sleep

Description

Wrist Actigraphy will be used to measure sleep (mean duration of sleep) at baseline and 12-month follow-up.

Time Frame

At baseline and 12 months

Title

Sleep

Description

Wrist Actigraphy will be used to measure sleep (mean sleep efficiency) at baseline and 12-month follow-up.

Time Frame

At baseline and 12 months

Title

Sleep

Description

Wrist Actigraphy will be used to measure sleep (mean wake after sleep onset) at baseline and 12-month follow-up.

Time Frame

At baseline and 12 months

Title

Hemoglobin A1c (HbA1c)

Description

Time Frame

At baseline and 12 months

Title

Lipids

Description

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.

Time Frame

At baseline and 12 months

Other Pre-specified Outcome Measures:

Title

Utilize Reach Effectiveness Adoption Implementation (RE-AIM) to evaluate the intervention's dissemination potential

Description

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.

Time Frame

12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sharon J Herring, MD MPH

Organizational Affiliation

Temple University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Temple University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

Learn more about this trial

Community-based Obesity Treatment in African American Women After Childbirth

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