#BabyLetsMove Physical Activity Feasibility Trial

NCT04628065 | Completed

• 2 other identifiers: 2017-00241U54GM115428
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy Related; Adolescent Obesity; Behavior, Health; Behavior, Sedentary; Adolescent Overweight; Mobile Phone Use; Pregnancy in Adolescence

Keywords

Pregnancy in adolescence; Exercise; Physical activity; Sedentary behavior; mHealth; Obesity in pregnancy; Adolescent obesity; Adolescent overweight; Behavioral science; Implementation science; Clinical trial

Outcome Measures

Primary Outcomes (2)

• Physical activity

  Objective physical activity assessed using Actigraph GT9X accelerometry worn for seven consecutive days

  Baseline, pre-intervention

• Sedentary time

  Objective physical activity assessed using Actigraph GT9X accelerometry worn for seven consecutive days

  Baseline, pre-intervention

Secondary Outcomes (10)

• Body weight

  Baseline, pre-intervention

• Readiness for physical activity in pregnancy

  Baseline, pre-intervention

• Self-efficacy for physical activity

  Baseline, pre-intervention

• Self-efficacy for overcoming self-identified barriers to physical activity

  Baseline, pre-intervention

• Self-efficacy for limiting sedentary time

  Baseline, pre-intervention

Other Outcomes (40)

• Organizational Identification

  Baseline, pre-intervention

• Inner Setting

  Baseline, pre-intervention

• Organizational Climate

  Baseline, pre-intervention

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Participants will receive a text message everyday to build behavioral skills and practice self-monitoring of three behavior goals: (1) reduce TV time to less than 2 hours per day; (2) take 10,000 steps or more every day; (3) do 20 minutes or more of structures exercise like prenatal yoga or dance videos every day. Participants will also receive two health coaching mobile phone session; an introduction session and one problem solving session.

Behavioral: #BabyLetsMove

Interventions

#BabyLetsMove BEHAVIORAL

This intervention will use mobile phones to promote the adoption and maintenance of physical activity, exercise and reduced TV time among overweight or obese, Black, pregnant (\<16 weeks) adolescents (15 - 19 years) enrolled in Mississippi's WIC program.

Intervention Arm

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• African American or Black
• \<16 weeks gestation
• Overweight or obese
• Enrolled in WIC
• Resides in one of 13 Mississippi Delta Counties
• Cohabitation with their mother
• Has a personal smart phone

You may not qualify if:

• Been told by a doctor they can not exercise

Sponsors & Collaborators

• University of Mississippi Medical Center: lead
• National Institute of General Medical Sciences (NIGMS): collaborator
• Mississippi State Department of Health: collaborator

Study Sites (1)

Mississippi State Department of Health

Jackson, Mississippi, 39216, United States

Location

Related Publications (4)

• Gamble A, Baskin ML, Cranston KL, Herring SJ, Hinton E, Saulters MM, Moore JB, Welsch MA, Beech BM. Effects of eHealth interventions on physical activity and weight among pregnant and postpartum women and the sociodemographic characteristics of study populations: a systematic review protocol. JBI Evid Synth. 2020 Nov;18(11):2396-2403. doi: 10.11124/JBISRIR-D-19-00378.

  PMID: 32813415 BACKGROUND

• Gamble A, Saulters MM, Cranston KL, Jones DW, Herring SJ, Beech BM. Recruitment, Retention, and Engagement Strategies for Exercise Interventions With Rural Antenatal Adolescents: Qualitative Interviews With WIC Providers. J Public Health Manag Pract. 2020 Sep/Oct;26(5):497-502. doi: 10.1097/PHH.0000000000001027.

  PMID: 32732725 RESULT

• Gamble A, Beech BM, Blackshear C, Cranston KL, Herring SJ, Moore JB, Welsch MA. Recruitment planning for clinical trials with a vulnerable perinatal adolescent population using the Clinical Trials Transformative Initiative framework and principles of partner and community engagement. Contemp Clin Trials. 2021 May;104:106363. doi: 10.1016/j.cct.2021.106363. Epub 2021 Mar 15.

  PMID: 33737198 RESULT

• Gamble A, Beech BM, Blackshear C, Herring SJ, Welsch MA, Moore JB. Changes in Physical Activity and Television Viewing From Pre-pregnancy Through Postpartum Among a Socioeconomically Disadvantaged Perinatal Adolescent Population. J Pediatr Adolesc Gynecol. 2021 Dec;34(6):832-838. doi: 10.1016/j.jpag.2021.06.009. Epub 2021 Jul 13.

  PMID: 34271198 RESULT

MeSH Terms

Conditions

Pediatric Obesity; Health Behavior; Sedentary Behavior; Cell Phone Use; Motor Activity; Pregnancy in Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Communication; Social Behavior; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Abigail Gamble, PhD, MS

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 13, 2020
• Study Start: March 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)