NCT03532048

Feasibility of Healthy Dads Healthy Kids Latino

Completed NA Results posted Last updated 3 March 2021

What this trial tests

NA trial testing The Papás Saludables, Niños Saludables Program in Feasibility in 160 participants. Completed in 6 May 2019.

Timeline

11 August 2018

Primary endpoint
6 May 2019

6 May 2019

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	160
Start date	11 August 2018
Primary completion	6 May 2019
Estimated completion	6 May 2019
Sites	1 location across United States

Drugs / interventions tested

• The Papás Saludables, Niños Saludables Program
• The Papás Saludables, Niños Saludables Wait-list Control

Conditions studied

• Feasibility — all drugs for Feasibility →

Sponsor

Baylor College of Medicine

Who can join

Adults 5 to 65, any sex, with Feasibility. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Retention of Subjects in Study Assessments Primary · 5 months

Retain 80% of intervention and control participants for pre- and post-assessments

Group	Value	95% CI
Intervention Group	14
Wait-list Control	13

Recruitment of Subjects Into Study Primary · 4 months

Recruitment criteria was to recruit 40 Latino fathers and their families in ≤ 4 months. The actual recruited number of fathers with their family is reported as the outcome withe the percentage of goal achieved (actual/goal).

Group	Value	95% CI
Intervention Group	19
Wait-list Control	17

Subject Attendance to Program Sessions Primary · 10 weeks

Attendance of families to the 10 PSNS program sessions were recorded each week for the intervention group and later the wait-list control group. The goals was to maintain ≥70% attendance to program sessions

Group	Value	95% CI
Intervention Group	5.6	± 4.1
Wait-list Control	5.6	± 3.8

Percentage of Fathers and Mothers Who Reported Their Satisfaction With the PSNS Program as Excellent to Good on the "Healthy Dads Healthy Kids Satisfaction Survey" Secondary · 10 weeks

The participating Latino fathers will be satisfied with the program as measured by 80% 'excellent'-'good' satisfaction from questionnaires and exit interviews with the Latino fathers and their co-parent (typically children's mother).

Group	Value	95% CI
Intervention Group	24
Wait-list Control	23

Data Collection Completeness Secondary · 5 months

Ability to collect anthropometric, behavioral and parenting data on at least 75% of the Latino fathers and anthropometric, and behavioral data on their children (both groups) at baseline and follow up

Group	Value	95% CI
Intervention Group	13
Wait-list Control	13

Sponsor's own description

This is a feasibility study of a culturally adapted version of Healthy Dads Healthy Kids for Hispanic families. The adapted version called Papás Saludables, Niños Saludables is a father-targeted program for child obesity prevention and weight loss for fathers. The feasibility study will be conducted with 40 Hispanic families. Baseline assessments (T0) will be completed on all participating family members, followed by randomization to start the program immediately (intervention group), or 6-7 months later (wait-list control). Post assessments (T1) will be completed on the full sample once the intervention group has participated in the 10 week Papás Saludables, Niños Saludables program. A process evaluation will be conducted to assess the feasibility outcomes of the study.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions to prevent obesity in children aged 5 to 11 years old.
   Spiga F, Davies AL, Tomlinson E, Moore TH, et al · · 2024 · cited 40× · PMID 38763517 · DOI 10.1002/14651858.cd015328.pub2
2. Feasibility of Targeting Hispanic Fathers and Children in an Obesity Intervention: <i>Papás Saludables Niños Saludables</i>.
   O'Connor TM, Beltran A, Musaad S, Perez O, et al · · 2020 · cited 27× · PMID 32466678 · DOI 10.1089/chi.2020.0006
3. Papás Saludables, Niños Saludables: Perspectives From Hispanic Parents and Children in a Culturally Adapted Father-Focused Obesity Program.
   Perez O, Beltran A, Isbell T, Galdamez-Calderon E, et al · · 2021 · cited 8× · PMID 33358181 · DOI 10.1016/j.jneb.2020.11.006