Community-based Obesity Treatment in African American Women After Childbirth

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02829229
• Other study ID #: 23187
• Secondary ID: R01HL130816
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: June 2021

Study information

• Verified date: July 2022
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Self-identification as African American

2. Self-report pre-pregnancy BMI between 25-49.9 kg/m2

3. Measured BMI at baseline between 25-49.9 kg/m2

4. Philadelphia WIC participant

5. Singleton birth

6. Between 1 and 6 months postpartum

7. Own a cell phone with an unlimited text messaging plan

8. Able to participate in light physical activity (walking)

9. Participants must be willing to comply with all study-related procedures

10. Participants must be able to read and write fluently in English

Exclusion Criteria:

1. BMI = 24.9 or = 50.0 kg/m2

2. 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.

3. Known atherosclerotic cardiovascular disease

4. Known congestive heart failure

5. Known diabetes mellitus (type 1 or type 2)

6. Known thyroid disease

7. Any major active rheumatologic, pulmonary, hepatic, dermatologic disease or inflammatory condition requiring steroids or immune modulating medications

8. History of testing HIV positive

9. Current smoker or tobacco user. Participants with < 5 cigarettes daily are allowable

10. Current or recent history (past 6 months) of drug or alcohol abuse or dependence

11. Participation in any weight control or investigational drug study within 6 weeks of screening

12. Current consumption of any of the following medications: appetite suppressants, anti-psychotics, lipase inhibitors

13. 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

14. Gastrointestinal Disorders (gallbladder disease, Crohn's disease, etc)

15. Previous weight loss surgery

16. History of bulimia or anorexia

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Community-based obesity treatment (PP)
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.

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Utilize Reach Effectiveness Adoption Implementation (RE-AIM) to evaluate the intervention's dissemination potential	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.	12 months
Primary	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.	At baseline and 12 months
Secondary	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.	At baseline and 12 months
Secondary	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.	At baseline and 12 months
Secondary	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.	At baseline and 12 months
Secondary	Physical Activity	Wrist Actigraphy will be used to measure physical activity (average number of steps) at baseline and 12-month follow-up.	At baseline and 12 months
Secondary	Physical Activity	Wrist Actigraphy will be used to measure physical activity (average intensity of activity) at baseline and 12-month follow-up.	At baseline and 12 months
Secondary	Sleep	Wrist Actigraphy will be used to measure sleep (mean duration of sleep) at baseline and 12-month follow-up.	At baseline and 12 months
Secondary	Sleep	Wrist Actigraphy will be used to measure sleep (mean sleep efficiency) at baseline and 12-month follow-up.	At baseline and 12 months
Secondary	Sleep	Wrist Actigraphy will be used to measure sleep (mean wake after sleep onset) at baseline and 12-month follow-up.	At baseline and 12 months
Secondary	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.	At baseline and 12 months
Secondary	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.	At baseline and 12 months