Clinical trial NCT03433456: Healthy Homes, Healthy Habits
Official title: Leveraging Ongoing Home Visitation Programs to Address Obesity Disparities Among Underserved, Low-Income Mothers and Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Obesity, Childhood
Obesity; Familial
Keywords: obesity
low-income
health disparities
home visitation
prevention
childhood obesity
habit
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2018-02-14
Enrollment: 296
Sex: ALL
Minimum age (years): 0
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Caregiver-child dyads will be randomized to either the intervention group (receiving home intervention + HABITS program) or the a control group to receive their standard of care (home intervention without HABITS)
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight of Mothers
timeFrame: Baseline, 6 months, 12 months
measure: Weight of Children
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Habit Strength of Targeted Behaviors
timeFrame: Baseline, 6 months, 12 months
measure: Household Environment Assessing the Number of Different Food Items Available
timeFrame: Baseline, 6 months, 12 months
measure: Household Environment Assessing the Number of Different Activity-promoting Items Available
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
measure: Maternal Eating Practices
timeFrame: Baseline, 6 months, 12 months
measure: Maternal Feeding Practices
timeFrame: Baseline, 6 months, 12 months
measure: Caregiver Depressive Symptoms on the Personal Health Questionnaire Depression Scale (PHQ-8)
timeFrame: Baseline, 6 months, 12 months
measure: Number of Caregivers With Changes to Their Medical History
timeFrame: 6 months, 12 months
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Sarah J. Salvy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Gareth R. Dutton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.