Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03433456
Other study ID # 000517527
Secondary ID 2U54MD000502-15
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 2, 2019
Est. completion date July 31, 2024

Study information

Verified date March 2024
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether an intervention targeting healthy habit development reduces the risk and prevalence of obesity in low-income mothers and children. The study intends to evaluate whether the intervention, delivered in the context of home visitation services for low-income families, reduces weight gain and risk factors associated with parent and childhood obesity compared to those receiving standard home visitation services.


Description:

Participants will be 140 mothers (>50% African American; 100% meet federal poverty level) and their children (n=140; 0-4yo at baseline) (total of N=140 mother-child dyads; i.e., 140 mothers + 140 children = 280 total participants) enrolled in our home visitation partner in central Alabama. Home visitors will be randomly assigned to deliver the home visitation curriculum with or without HABITS (an obesity prevention program targeting key eating and activity behaviors) as part of their monthly home visits for 12 months. Treatment sessions for standard of care or standard + HABITS arms will be facilitated by trained home visitors. If a mother or primary caregiver and her child are randomized to participate in the HABITS + Standard home visitation curriculum, they will receive ~15 minutes of information, activities, and assistance regarding the development of key behaviors relating to obesity prevention, which will be imbedded within the existing home visitation curriculum. The HABITS program will address habit-formation of four behaviors relevant to mothers or primary caregivers and children: (1) limit fried foods; (2) limit sugar-sweetened beverages (SSB); (3) increase daily steps; (4) increase fruits and vegetables. Additionally, mothers or primary caregivers will also practice habit formation focused on self-monitoring of weight and the four behaviors previously mentioned. Skill training will focus on habit formation and home environment modification conducive to the four behaviors. Mothers or primary caregivers in the intervention group will be provided the HABITS + standard home visitation program for 12 months, while those in the control group will be provided the standard home visitation program during this time. Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 296
Est. completion date July 31, 2024
Est. primary completion date February 27, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 0 Years to 75 Years
Eligibility Inclusion Criteria: *Important: Mother (or caregiver) and child dyads are enrolled together. Both must meet inclusion criteria to participate. Mothers or Primary Caregivers: - Age 18-75 years of age - Enrollment in First Teacher Home Visiting Program (First Teacher) through the Family Guidance Center of Alabama. - Mother or primary caregiver of 0-4 year old child - Generally Healthy Children: - 0-4 years of age at time of enrollment - Parent or primary caregiver enrolled in First Teacher Exclusion Criteria: Mothers or primary caregivers: - Currently enrolled in a diet and weight loss program, AND either a) significant weight loss of 10+ pounds in the last 6 months, OR b) unwilling to discontinue from current diet and weight loss program. Children: - Child has a history of a feeding or eating disorder

Study Design


Intervention

Behavioral:
Home visitation + HABITS program
The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.
Standard home visitation program
Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (2)

Lead Sponsor Collaborator
University of Alabama at Birmingham National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Salvy SJ, Dutton GR, Borgatti A, Kim YI. Habit formation intervention to prevent obesity in low-income preschoolers and their mothers: A randomized controlled trial protocol. Contemp Clin Trials. 2018 Jul;70:88-98. doi: 10.1016/j.cct.2018.05.015. Epub 2018 May 24. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Maternal Eating Practices Assessed using modified food and activity frequency measure from the National Health and Nutrition Examination Survey (NHANES), amended to measure target habit behaviors of feeding and activity. Scored on a scale from 0-6 with higher values indicated more frequent consumption of that food or engagement in that behavior. Baseline, 6 months, 12 months
Other Maternal Feeding Practices Assessed using modified food and activity frequency measure from NHANES, amended to measure target habit behaviors of feeding and activity. Scored from 0-7 with higher values indicated more frequent consumption of food or engagement in the behavior. Baseline, 6 months, 12 months
Other Caregiver Depressive Symptoms on the Personal Health Questionnaire Depression Scale (PHQ-8) The Personal Health Questionnaire Depression Scale (PHQ-8), a validated self-report measure of depressive symptoms experienced over the past two weeks, will be administered to caregivers. PHQ-8 scores range from 0-24, higher scores indicate higher caregiver depressive symptoms. Baseline, 6 months, 12 months
Other Number of Caregivers With Changes to Their Medical History Self-reported changes to medical history for caregivers (caregiver illnesses, etc.) will be collected. 6 months, 12 months
Primary Weight of Mothers Body weight (kg) at baseline and follow-up assessments. Baseline, 6 months, 12 months
Primary Weight of Children Body weight (kg) at baseline and follow-up assessments.. Baseline, 6 months, 12 months
Secondary Habit Strength of Targeted Behaviors Habit strength for caregivers will be assessed using the Self-Reported Habit Index (SRHI) specific to target behaviors on a scale from 1-5 with scores of 5 indicating higher caregiver habit strength for the target behavior. Baseline, 6 months, 12 months
Secondary Household Environment Assessing the Number of Different Food Items Available Household environment assessing the number of different food items available in the home of the caregiver will be assessed using a modified Home Food Assessment (HFA) relating to the 4 food-related target behaviors (fruits, vegetables, sugary beverages, and fried foods). Higher values indicate more different food items in that category (fruits, vegetables, sugary beverages, and fried foods) are available within the home. Baseline, 6 months, 12 months
Secondary Household Environment Assessing the Number of Different Activity-promoting Items Available Household environment assessing the number of different activity-promoting items available in the home of the caregiver will be assessed using a modified Home - Inventory Describing Eating and Activity Development (H-IDEA) form. Higher values indicate more availability of different activity-promoting items in the home. Baseline, 6 months, 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2