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Physical Activity in Women With Infants

Physical Activity in Women With Infants

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00810342
Acronym
NaMikimiki
Enrollment
311
Registered
2008-12-18
Start date
2008-04-30
Completion date
2012-07-31
Last updated
2015-06-04

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

Conditions

Physical Activity

Keywords

physical activity standard, exercise

Brief summary

This is a study testing ways to motivate new mothers to become more physically active over a one year period.

Detailed description

Mothers of an infant are much less likely to exercise regularly compared with women who have older children or no children. This low level of physical activity (PA) contributes to postpartum weight retention which can predict levels of obesity up to 15 years later. Ethnic minorities have higher rates of inactivity and gain more weight following childbirth, which places them at increased risk for cancer and other chronic diseases consistent with known health disparities for these ethnic groups. Few PA interventions have been designed to increase PA in women with an infant, especially ethnic minority women. This study will test the efficacy of a tailored intervention to increase and maintain PA in a multiethnic population of 268 young, healthy postpartum women living in Hawaii. Women will be recruited from health care settings, mother/baby support groups, and from the media campaigns(TV, radio, newspaper, parents magazines). Subjects will be randomly assigned to either a tailored postpartum counseling intervention on PA or standard care for PA. The tailored PA intervention will address key personal, social, and environmental factors derived from Social Cognitive Theory and the Transtheoretical Model. Also, multimodal contacts (telephone, e-mail, website) will be used to deliver theoretically-derived, culturally sensitive PA counseling,behavioral skills training (e.g., goal setting), and local resources/referrals tailored to a mother with an infant. The standard care condition receives American Heart Association/American College of Sports Medicine print materials/e-mails and referral to PA internet resources. The primary PA outcome is minutes of moderate/vigorous physical activity (MVPA) per week, as measured by the Active Australia Questionnaire, with validation by accelerometers worn by all subjects. Condition differences in the initiation of PA will be tested at 6 and 12 months post-baseline. Key psychosocial, physiological, and cultural factors will be tested as mediators or moderators of PA, for example: self-efficacy, social support, processes of change, ethnicity, BMI, and cultural values. This study will serve as a model for the design and implementation of PA interventions for at-risk ethnic minority postpartum women.

Interventions

BEHAVIORALphysical activity tailored

tailored telephone counseling, email feedback, and website resources over 12 months

BEHAVIORALphysical activity standard

standard print and website information on how to become more active

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Hawaii
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* mother of infant aged 2-12 months * sedentary * healthy, able to do moderate intensity physical activity * BMI = 18.5-40 * not planning to become pregnant in next year * woman aged 18-45 * able speak and read English

Exclusion criteria

* pregnant * planning to leave Oahu, Hawaii in the next year (permanently move away) * a diagnosis of cancer, coronary heart disease (including atrial fibrillation), insulin-dependent diabetes mellitus (IDDM), and other atherosclerotic cardiovascular diseases (e.g., stroke),

Design outcomes

Primary

MeasureTime frameDescription
Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months12 monthsSelf reported minutes of moderate or vigorous physical activity per week after 12-months

Secondary

MeasureTime frameDescription
Accelerometer Collected Moderate to Vigorous Physical Activity12-MonthsParticipant's physical activity (overall moderate-to-vigorous physical activity above 2.9 metabolic equivalents (METs) collected via an accelerometer over 12 months

Countries

United States

Participant flow

Participants by arm

ArmCount
1- Tailored
Tailored telephone counseling about how to become more physically active. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active. physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months
154
2 - Standard
Website resources on physical activity physical activity: standard print and website information on how to become more active
157
Total311

Withdrawals & dropouts

PeriodReasonFG000FG001
12-month FollowupLost to Follow-up31
12-month FollowupPregnancy910
6-month Follow-upLost to Follow-up186
6-month Follow-upPregnancy62
Month 1 Follow-upLost to Follow-up42
Month 1 Follow-upPregnancy10

Baseline characteristics

Characteristic1- Tailored2 - StandardTotal
Age, Continuous31.6 years
STANDARD_DEVIATION 5.5
32.1 years
STANDARD_DEVIATION 5.9
31.8 years
STANDARD_DEVIATION 5.7
Ethnicity (NIH/OMB)
Hispanic or Latino
24 Participants30 Participants54 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
128 Participants124 Participants252 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants3 Participants5 Participants
Minutes per week of moderate-to-vigorous physical activity44 minutes per week46 minutes per week45 minutes per week
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
53 Participants52 Participants105 Participants
Race (NIH/OMB)
Black or African American
4 Participants4 Participants8 Participants
Race (NIH/OMB)
More than one race
27 Participants24 Participants51 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
49 Participants49 Participants98 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants2 Participants
Race (NIH/OMB)
White
20 Participants27 Participants47 Participants
Region of Enrollment
United States
154 participants157 participants311 participants
Sex: Female, Male
Female
154 Participants157 Participants311 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
4 / 1542 / 157
serious
Total, serious adverse events
2 / 1542 / 157

Outcome results

Primary

Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months

Self reported minutes of moderate or vigorous physical activity per week after 12-months

Time frame: 12 months

Population: Treatment effect was assessed by a mixed growth model and the F test of the fixed 2-way interaction parameter for time and study condition for overall and of the 3-way interaction parameter for characteristic level, time, and study condition. Adjusted for age, race, BMI, education, #children, employment, depression, baby's age, years in Hawaii

ArmMeasureValue (MEAN)
1- TailoredMinutes of Moderate or Vigorous Physical Activity Per Week After 12-months246 minutes per week moderate-to-vigorous PA
2 - StandardMinutes of Moderate or Vigorous Physical Activity Per Week After 12-months156 minutes per week moderate-to-vigorous PA
Secondary

Accelerometer Collected Moderate to Vigorous Physical Activity

Participant's physical activity (overall moderate-to-vigorous physical activity above 2.9 metabolic equivalents (METs) collected via an accelerometer over 12 months

Time frame: 12-Months

Population: Treatment effect was assessed by a mixed growth model and the F test of the fixed 2-way interaction parameter for time and study condition for overall and of the 3-way interaction parameter for characteristic level, time, and study condition. Adjusted for age, race, BMI, education, #children, employment, depression, baby's age, years in Hawaii

ArmMeasureValue (MEAN)
1- TailoredAccelerometer Collected Moderate to Vigorous Physical Activity215 minutes per week moderate-to-vigorous PA
2 - StandardAccelerometer Collected Moderate to Vigorous Physical Activity203 minutes per week moderate-to-vigorous PA

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026