Clinical trial NCT04628065: #BabyLetsMove Physical Activity Feasibility Trial
Official title: #BabyLetsMove: A Feasibility Study of a mHealth Physical Activity Intervention for Perinatal Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
name: Mississippi State Department of Health
First posted: 2020-11-13
Enrollment: 14
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Detailed description: Formative research is needed to establish a foundation for obesity prevention research with high-risk, disadvantaged, perinatal adolescents and their offspring. In particular, Black pregnant adolescents in socioeconomically disadvantaged communities represent a high-risk and understudied perinatal population in health research. Adolescent pregnancy (\<20 years) is disproportionately prevalent among Blacks compared with Whites (27.6 and 13.4 per 1,000, respectively) and is a prominent risk factor for obesity. Normal pubertal growth is associated with increased weight in adolescence and Black female and rural adolescents are at highest risk for excessive adiposity. Pregnancy exacerbates preexisting risks and predicates a trajectory of maternal and child obesity. Fortunately, metabolic consequences of increasing physical activity coupled with minimal sedentary behavior can mitigate biological imperils and behavioral interventions targeting perinatal populations have demonstrated efficacy for this approach. Intervention studies to promote physical activity and reduce sedentary behavior among Black, perinatal adolescents in disadvantaged, rural settings may be a promising strategy to prevent obesity and reduce disparities. To this end, investigators conducted formative work in the Teen Mom Study, an exploratory investigation to identify modifiable psychosocial, cultural and environmental determinants of physical activity among pregnant and postpartum adolescents enrolled in Mississippi's Supplemental Nutritional Program for Women Infants and Children (WIC) in the Mississippi Delta. WIC is a federally-funded, state-run public health service providing healthy food and nutrition counseling to low-income women, infants and children at nutritional risk. Public health services like WIC are ideal settings for the prevention and treatment of obesity among high-risk, socioeconomically disadvantaged populations. The Mississippi Delta is a culturally and geographically distinct 18-county rural region of Mississippi that is plagued by decades of persistent poverty, poor health and the highest teen birth rate, which has not declined since 2006, in the United States. Using data from the Teen Mom Study, investigators adapted an existing mobile health (mHealth) intervention to achieve 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; tracked using a FitBit provided to each study participant); 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 overweight or obese, Black, pregnant (\<16 weeks) adolescent (15 - 19 years) WIC clients to test the feasibility and acceptability of the intervention. Participants will receive text messages aligned with theoretical behavior change strategies every day of the week for 4-weeks including: 1) four skills texts, which may be a simple text or a text with a link to either a PDF or video; 2) two goal monitoring text messages, which will check-in on the three behavior change goals; and 3) and one text message for participants to report their weight using a BodyTrace scale provided by the study. Text messages will be supplemented with two health coaching telephone calls conducted by the principal investigator; an introduction session in the first week, followed by a problem-solving session in week three. While the study goal is to assess feasibility and acceptability, physical activity assessed using accelerometry, subjective psychosocial constructs, and anthropometric and biomarker measures will be measured at pre- (week 1) and post- (week 6) intervention. To gain additional insight, investigators will use qualitative interviewing with additional adolescents (n=20) to solicit user feedback regarding the acceptability of intervention content (text messages) and materials (PDFs and videos). Finally, in preparation for a randomized pilot trial using an effectiveness-implementation hybrid research design, investigators will conduct a pre-implementation evaluation using quantitative surveying (n=6 surveys) with WIC providers (n=60) to better under the context, culture and climate of WIC (implementation measures identified in the Consolidated Framework for Implementation Research). Investigators hypothesize the #BabyLetsMove intervention materials will be acceptable to adolescents and that conducting 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. If proven to be effective, #BabyLetsMove mHealth intervention may be a scalable approach to increase physical activity among socioeconomically disadvantaged adolescents at high risk for maternal and child obesity.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Been told by a doctor they can not exercise

Primary outcomes:
measure: Physical activity
timeFrame: Baseline, pre-intervention
measure: Sedentary time
timeFrame: Baseline, pre-intervention
Secondary outcomes:
measure: Body weight
timeFrame: Baseline, pre-intervention
measure: Readiness for physical activity in pregnancy
timeFrame: Baseline, pre-intervention
measure: Self-efficacy for physical activity
timeFrame: Baseline, pre-intervention
measure: Self-efficacy for overcoming self-identified barriers to physical activity
timeFrame: Baseline, pre-intervention
measure: Self-efficacy for limiting sedentary time
timeFrame: Baseline, pre-intervention
measure: Self-regulation: Goal-Setting
timeFrame: Baseline, pre-intervention
measure: Self-regulation: Planning
timeFrame: Baseline, pre-intervention
measure: Decisional balance
timeFrame: Baseline, pre-intervention
measure: Perceived exercise safety in pregnancy
timeFrame: Baseline, pre-intervention
measure: Perceived daily physical activity behavior
timeFrame: Baseline, pre-intervention
Other outcomes:
measure: Organizational Identification
timeFrame: Baseline, pre-intervention
measure: Inner Setting
timeFrame: Baseline, pre-intervention
measure: Organizational Climate
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: quantitative demands
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: work pace
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: cognitive demands
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: emotional demands
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: demands for hiding emotions
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: influence
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: possibilities for development
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: variation of work
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: meaning of work
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: commitment to the workplace
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: predictability
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: rewards (recognition)
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: role clarity
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: role conflicts
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: perceived quality of leadership
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: social support from supervisor
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: social support from colleagues
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: social community at work
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: job insecurity
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: perceived job satisfaction
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: work-family conflict
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: family-work conflict
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: trust regarding management
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: mutual trust between employees
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: justice and respect
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: social responsibility
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: self rated health
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: burnout
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: stress
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: sleeping troubles
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: depressive symptoms
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: somatic stress symptoms
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: cognitive stress symptoms
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: perceived self-efficacy for life solving problems
timeFrame: Baseline, pre-intervention
measure: Psychosocial factors at work: conflicts and offensive behaviors
timeFrame: Baseline, pre-intervention
measure: Occupational Self-efficacy for performing job-related duties
timeFrame: Baseline, pre-intervention
measure: Organizational culture
timeFrame: Baseline, pre-intervention
Locations:
city: Jackson
country: United States
facility: Mississippi State Department of Health
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Abigail Gamble, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.