NCT00810342

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
311

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2008

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

June 4, 2015

Completed
Last Updated

June 4, 2015

Status Verified

January 1, 2015

Enrollment Period

4.3 years

First QC Date

December 17, 2008

Results QC Date

January 9, 2015

Last Update Submit

June 1, 2015

Conditions

Physical Activity

Keywords

physical activity standardexercise

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Secondary Outcomes (1)

  • Accelerometer Collected Moderate to Vigorous Physical Activity

    12-Months

Study Arms (2)

1- physical activity tailored

EXPERIMENTAL

Tailored telephone counseling about how to become more physically active and goal setting. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.

Behavioral: physical activity tailored

2 - physical activity standard

ACTIVE COMPARATOR

Standard Website resources / information on physical activity

Behavioral: physical activity standard

Interventions

physical activity tailoredBEHAVIORAL

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

Also known as: tailored exercise advice
1- physical activity tailored
physical activity standardBEHAVIORAL

standard print and website information on how to become more active

Also known as: standard information about physical activity
2 - physical activity standard

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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),

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hawaii School of Nursing

Honolulu, Hawaii, 96822, United States

Location

Related Publications (2)

  • Albright CL, Saiki K, Steffen AD, Woekel E. What barriers thwart postpartum women's physical activity goals during a 12-month intervention? A process evaluation of the Na Mikimiki Project. Women Health. 2015;55(1):1-21. doi: 10.1080/03630242.2014.972014. Epub 2015 Jan 30.

    PMID: 25402618DERIVED

  • Albright CL, Steffen AD, Novotny R, Nigg CR, Wilkens LR, Saiki K, Yamada P, Hedemark B, Maddock JE, Dunn AL, Brown WJ. Baseline results from Hawaii's Na Mikimiki Project: a physical activity intervention tailored to multiethnic postpartum women. Women Health. 2012;52(3):265-91. doi: 10.1080/03630242.2012.662935.

    PMID: 22533900DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Cheryl Albright
Organization
University of Hawaii, School of Nursing
cherylal@hawaii.edu
8089569716

Study Officials

  • Cheryl L Albright, PhD, MPH

    University of Hawaii, School of Nursing and Dental Hygiene

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2008

First Posted

December 18, 2008

Study Start

April 1, 2008

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

June 4, 2015

Results First Posted

June 4, 2015

Record last verified: 2015-01

Locations

US(1)