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#BabyLetsMove Physical Activity Feasibility Trial

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04628065
Enrollment
14
Registered
2020-11-13
Start date
2021-03-01
Completion date
2022-06-30
Last updated
2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

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.

Sponsors

National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH
Mississippi State Department of Health
CollaboratorOTHER_GOV
University of Mississippi Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 19 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Physical activityBaseline, pre-interventionObjective physical activity assessed using Actigraph GT9X accelerometry worn for seven consecutive days
Sedentary timeBaseline, pre-interventionObjective physical activity assessed using Actigraph GT9X accelerometry worn for seven consecutive days

Secondary

MeasureTime frameDescription
Readiness for physical activity in pregnancyBaseline, pre-interventionSingle response item to categorize readiness to engage in physical activity; Haakstad et al., 2013 (PMID:23431448)
Self-efficacy for physical activityBaseline, pre-intervention5-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
Self-efficacy for overcoming self-identified barriers to physical activityBaseline, pre-interventionUp 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
Self-efficacy for limiting sedentary timeBaseline, pre-intervention6-item instrument to rate confidence in limiting sedentary time using an 11-point Likert scale from 0, absolutely not confident, to 100, absolutely confident;
Self-regulation: PlanningBaseline, pre-interventionExercise Planning Scale; 10 items rated using a 5-point Likert scale from 1, does not describe me, to 5, describes me completely
Decisional balanceBaseline, pre-interventionPros and Cons of Reducing TV Time; 11-items rated using 4-point Likert scale from 1, strongly disagree to 4, strongly agree
Perceived exercise safety in pregnancyBaseline, pre-interventionExercise Safety Scale; 14 items rated using a 4-point Likert scale from 1, very unsafe to 4, very safe
Perceived daily physical activity behaviorBaseline, pre-interventionPregnancy 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
Self-regulation: Goal-SettingBaseline, pre-interventionExercise Goal-Setting Scale; 10 items rated using a 5-point Likert scale from 1, does not describe me, to 5, describes me completely
Body weightBaseline, pre-interventionBodyTrace scale with Bluetooth

Other

MeasureTime frameDescription
Psychosocial factors at work: commitment to the workplaceBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: predictabilityBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: rewards (recognition)Baseline, pre-interventionCopenhagen 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
Psychosocial factors at work: role clarityBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: role conflictsBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: perceived quality of leadershipBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: social support from supervisorBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: social support from colleaguesBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: social community at workBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: job insecurityBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: perceived job satisfactionBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: work-family conflictBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: family-work conflictBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: trust regarding managementBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: mutual trust between employeesBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: justice and respectBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: social responsibilityBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: self rated healthBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: burnoutBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: stressBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: emotional demandsBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: depressive symptomsBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: somatic stress symptomsBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: cognitive stress symptomsBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: perceived self-efficacy for life solving problemsBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: conflicts and offensive behaviorsBaseline, pre-interventionCopenhagen 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
Occupational Self-efficacy for performing job-related dutiesBaseline, pre-interventionOccupational Self-Efficacy Scale; 20-items rated using a 6-point Likert scale from 1, strongly disagree to 6, strongly agree
Organizational cultureBaseline, pre-interventionCompeting 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
Psychosocial factors at work: sleeping troublesBaseline, pre-interventionCopenhagen 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
Organizational IdentificationBaseline, pre-interventionOrganizational Identification Scale; 25-items rated using a 6-point Likert scale from 1, strongly disagree to 6, strongly agree
Inner SettingBaseline, pre-interventionInner 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
Organizational ClimateBaseline, pre-interventionOrganizational Climate Survey; 28-items using a 6-point Likert scale from strongly disagree to 6, strongly agree
Psychosocial factors at work: quantitative demandsBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: work paceBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: cognitive demandsBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: demands for hiding emotionsBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: influenceBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: possibilities for developmentBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: variation of workBaseline, pre-interventionCopenhagen 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
Psychosocial factors at work: meaning of workBaseline, pre-interventionCopenhagen 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026