NCT04628065

#BabyLetsMove Physical Activity Feasibility Trial

Completed NA Last updated 8 August 2022

What this trial tests

NA trial testing #BabyLetsMove in Pregnancy Related in 14 participants. Completed in 30 June 2022.

Timeline

1 March 2021

Primary endpoint
30 June 2022

30 June 2022

Quick facts

Lead sponsor	University of Mississippi Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	14
Start date	1 March 2021
Primary completion	30 June 2022
Estimated completion	30 June 2022
Sites	1 location across United States

Drugs / interventions tested

• #BabyLetsMove

Conditions studied

• Pregnancy Related — all drugs for Pregnancy Related →
• Adolescent Obesity — all drugs for Adolescent Obesity →
• Behavior, Health — all drugs for Behavior, Health →
• Behavior, Sedentary — all drugs for Behavior, Sedentary →

Sponsor

University of Mississippi Medical Center

Who can join

Adults 15 to 19, female only, with Pregnancy Related or Adolescent Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Black adolescents who are pregnant represent a high-risk and understudied perinatal population in health research. Adolescent pregnancy (\<20 years) is disproportionately prevalent among Blacks compared with Whites and is a prominent risk factor for obesity. Fortunately, metabolic consequences of increasing physical activity coupled with minimal sedentary time can mitigate biological imperils and behavioral interventions targeting perinatal populations have demonstrated efficacy for this approach. Intervention studies to promote physical activity and reduce sedentarism among Black, perinatal adolescents in disadvantaged, rural settings may be a promising strategy to prevent obesity and reduce disparities. In the proposed study, investigators will assess the feasibility and acceptability of #BabyLetsMove, a mobile health intervention targeting three behavioral goals: (1) limit TV time to less than 2 hours a day (sedentary behavior); (2) take 10,000 steps or more per day (physical activity); and (3) do 20 minutes or more of structured activity like prenatal yoga or dance videos per day (exercise). In the #BabyLetsMove feasibility trial investigators aim to conduct a single-arm, 4-week pilot with 20 Black adolescents (15- to 19-years) enrolled in Mississippi's Supplemental Nutritional Program for Women, Infants and Children (WIC) to test the intervention's feasibility and acceptability. Participants will receive one text message per day for 4-weeks targeting behavior change strategies and two health coaching sessions via mobile phone; an introduction session in week one and a problem-solving session in week three. Investigators will also use qualitative interviewing with additional adolescents (n=20) to solicit user feedback regarding the acceptability of intervention content and materials. Finally, in preparation for a pilot study using an effectiveness-implementation hybrid study design, investigators will conduct a pre-implementation evaluation using quantitative surveying (n=6 surveys) with WIC providers (n=60) to better under the culture and climate of WIC. Investigators hypothesize the #BabyLetsMove intervention will be acceptable to adolescents and a future pilot randomized controlled trial will be feasible. Investigators also anticipate identifying modifiable barriers and facilitators to implementing the intervention through WIC, which will help to design an implementation strategy with a high likelihood for uptake by WIC.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.