#BabyLetsMove Physical Activity Feasibility Trial

Pregnancy Related Clinical Trial

Official title:

#BabyLetsMove: A Feasibility Study of a mHealth Physical Activity Intervention for Perinatal Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04628065
• Other study ID #: 2017-0024
• Secondary ID: 1U54GM115428
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• #BabyLetsMove
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.

Locations

Country	Name	City	State
United States	Mississippi State Department of Health	Jackson	Mississippi

Sponsors (3)

Lead Sponsor	Collaborator
University of Mississippi Medical Center	Mississippi State Department of Health, National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

References & 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. — View 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 part — View 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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Organizational Identification	Organizational Identification Scale; 25-items rated using a 6-point Likert scale from 1, strongly disagree to 6, strongly agree	Baseline, pre-intervention
Other	Inner Setting	Inner Setting Measures from the Consolidated Framework for Implementation Research; 34-items rated using a 6-point Likert scale from 1, strongly disagree to 6, strongly agree	Baseline, pre-intervention
Other	Organizational Climate	Organizational Climate Survey; 28-items using a 6-point Likert scale from strongly disagree to 6, strongly agree	Baseline, pre-intervention
Other	Psychosocial factors at work: quantitative demands	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, never to 100, always	Baseline, pre-intervention
Other	Psychosocial factors at work: work pace	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 3-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent	Baseline, pre-intervention
Other	Psychosocial factors at work: cognitive demands	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, never to 100, always	Baseline, pre-intervention
Other	Psychosocial factors at work: emotional demands	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, never to 100, always	Baseline, pre-intervention
Other	Psychosocial factors at work: demands for hiding emotions	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 3-items using a 5-point Likert scale from 0, never to 100, always	Baseline, pre-intervention
Other	Psychosocial factors at work: influence	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, never to 100, always	Baseline, pre-intervention
Other	Psychosocial factors at work: possibilities for development	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent	Baseline, pre-intervention
Other	Psychosocial factors at work: variation of work	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 2-items using a 5-point Likert scale from 0, never to 100, always	Baseline, pre-intervention
Other	Psychosocial factors at work: meaning of work	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 3-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent	Baseline, pre-intervention
Other	Psychosocial factors at work: commitment to the workplace	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent	Baseline, pre-intervention
Other	Psychosocial factors at work: predictability	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 2-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent	Baseline, pre-intervention
Other	Psychosocial factors at work: rewards (recognition)	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 3-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent	Baseline, pre-intervention
Other	Psychosocial factors at work: role clarity	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 3-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent	Baseline, pre-intervention
Other	Psychosocial factors at work: role conflicts	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent	Baseline, pre-intervention
Other	Psychosocial factors at work: perceived quality of leadership	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent	Baseline, pre-intervention
Other	Psychosocial factors at work: social support from supervisor	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 3-items using a 5-point Likert scale from 0, never to 100, always	Baseline, pre-intervention
Other	Psychosocial factors at work: social support from colleagues	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 3-items using a 5-point Likert scale from 0, never to 100, always	Baseline, pre-intervention
Other	Psychosocial factors at work: social community at work	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 3-items using a 5-point Likert scale from 0, never to 100, always	Baseline, pre-intervention
Other	Psychosocial factors at work: job insecurity	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent	Baseline, pre-intervention
Other	Psychosocial factors at work: perceived job satisfaction	Copenhagen Psychosocial Questionnaire (COPSOQ-11) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, not relevant to 100, very satisfied	Baseline, pre-intervention
Other	Psychosocial factors at work: work-family conflict	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 4-point Likert scale from 0, no not at all to 100, yes certainly	Baseline, pre-intervention
Other	Psychosocial factors at work: family-work conflict	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 3-items using a 4-point Likert scale from 0, no not at all to 100, yes certainly	Baseline, pre-intervention
Other	Psychosocial factors at work: trust regarding management	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent	Baseline, pre-intervention
Other	Psychosocial factors at work: mutual trust between employees	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 3-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent	Baseline, pre-intervention
Other	Psychosocial factors at work: justice and respect	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent	Baseline, pre-intervention
Other	Psychosocial factors at work: social responsibility	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, to a very small extent to 100, to a very large extent	Baseline, pre-intervention
Other	Psychosocial factors at work: self rated health	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 1-item using a 5-point Likert scale from 0, poor to 100, excellent	Baseline, pre-intervention
Other	Psychosocial factors at work: burnout	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, not at all to 100, all the time	Baseline, pre-intervention
Other	Psychosocial factors at work: stress	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, not at all to 100, all the time	Baseline, pre-intervention
Other	Psychosocial factors at work: sleeping troubles	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, not at all to 100, all the time	Baseline, pre-intervention
Other	Psychosocial factors at work: depressive symptoms	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, not at all to 100, all the time	Baseline, pre-intervention
Other	Psychosocial factors at work: somatic stress symptoms	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, not at all to 100, all the time	Baseline, pre-intervention
Other	Psychosocial factors at work: cognitive stress symptoms	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 4-items using a 5-point Likert scale from 0, not at all to 100, all the time	Baseline, pre-intervention
Other	Psychosocial factors at work: perceived self-efficacy for life solving problems	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 6-items using a 4-point Likert scale from 0, does not fit to 100, fits perfectly	Baseline, pre-intervention
Other	Psychosocial factors at work: conflicts and offensive behaviors	Copenhagen Psychosocial Questionnaire (COPSOQ-II) long form; a battery of scales used in research to measure psychosocial factors at work (128-items total); 7-items using 5-point Likert scale from 0, no to 100, yes, daily	Baseline, pre-intervention
Other	Occupational Self-efficacy for performing job-related duties	Occupational Self-Efficacy Scale; 20-items rated using a 6-point Likert scale from 1, strongly disagree to 6, strongly agree	Baseline, pre-intervention
Other	Organizational culture	Competing Values Culture Assessment; 6-dimensions, 48-items assessing the present and future where the sum of 4-items per column (present; future) must equal 100; provides insight on how provider perceives the organization to be and must change to be in order to accomplish its highest objectives and goals	Baseline, pre-intervention
Primary	Physical activity	Objective physical activity assessed using Actigraph GT9X accelerometry worn for seven consecutive days	Baseline, pre-intervention
Primary	Sedentary time	Objective physical activity assessed using Actigraph GT9X accelerometry worn for seven consecutive days	Baseline, pre-intervention
Secondary	Body weight	BodyTrace scale with Bluetooth	Baseline, pre-intervention
Secondary	Readiness for physical activity in pregnancy	Single response item to categorize readiness to engage in physical activity; Haakstad et al., 2013 (PMID:23431448)	Baseline, pre-intervention
Secondary	Self-efficacy for physical activity	5-item survey to assess confidence in doing 20-minutes or more of moderate intensity on 1 day per week, 2 days, 3 days, 4 days, and 5 or more days; 11-point Likert scale from 0, absolutely not confident, to 100, absolutely confident	Baseline, pre-intervention
Secondary	Self-efficacy for overcoming self-identified barriers to physical activity	Up to 4-item instrument to list perceived barriers to physical activity and rating confidence to overcome each barrier using an 11-point Likert scale from 0, absolutely not confident, to 100, absolutely confident	Baseline, pre-intervention
Secondary	Self-efficacy for limiting sedentary time	6-item instrument to rate confidence in limiting sedentary time using an 11-point Likert scale from 0, absolutely not confident, to 100, absolutely confident;	Baseline, pre-intervention
Secondary	Self-regulation: Goal-Setting	Exercise Goal-Setting Scale; 10 items rated using a 5-point Likert scale from 1, does not describe me, to 5, describes me completely	Baseline, pre-intervention
Secondary	Self-regulation: Planning	Exercise Planning Scale; 10 items rated using a 5-point Likert scale from 1, does not describe me, to 5, describes me completely	Baseline, pre-intervention
Secondary	Decisional balance	Pros and Cons of Reducing TV Time; 11-items rated using 4-point Likert scale from 1, strongly disagree to 4, strongly agree	Baseline, pre-intervention
Secondary	Perceived exercise safety in pregnancy	Exercise Safety Scale; 14 items rated using a 4-point Likert scale from 1, very unsafe to 4, very safe	Baseline, pre-intervention
Secondary	Perceived daily physical activity behavior	Pregnancy Physical Activity Questionnaire; 32-item survey to assess type and duration of physical activities on a typical day within respective trimester using 6-point Likert scale from 0, non to 6, 3 or more hours per day	Baseline, pre-intervention