Condition category
Pregnancy and Childbirth
Date applied
12/02/2014
Date assigned
29/04/2014
Last edited
10/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of this study is to evaluate the effect of an online website to promote physical activity and prevent excess weight gain in previously low-active or sedentary pregnant women. We will also look at the impact of the mothers' physical activity and weight gain during pregnancy on their babies’ body measurements.

Who can participate?
Fifty healthy women between the ages of 18-45 years old, pregnant with one baby and less than 15 weeks gestation were recruited from central Iowa. Participants were low-active or sedentary, defined as less than three intentional bouts of 30 minutes of moderately intense physical activity per week for at least 6 months prior to conception.

What does the study involve?
Participants were randomly allocated to either a walking intervention or usual care between 10-14 weeks of pregnancy. Both groups of participants received access to the interactive website, but each group had access to different parts of the website. The usual care group had access to the part of the website that provided information about a healthy diet and physical activity recommendations specific to pregnancy. Women in the usual care group were not asked to make any specific changes to their physical activity and diet. The participants in the walking intervention group had access to the part of the website described above but also had access to the interactive part of the website. These participants were asked to gradually increase their physical activity to 30 minutes of walking on most if not all days of the week, to reach at least 150 minutes per week by week 19 of pregnancy, and continue until delivery. The mothers' weight gain during pregnancy was compared between the two groups, along with their adherence to the physical activity guidelines and their babies' body measurements at 1 month of age.

What are the possible benefits and risks of participating?
There was no immediate direct benefit from taking part in this study. If assigned to the walking intervention, participants were encouraged to participate in more physical activity during pregnancy and meet current prenatal physical activity recommendations. The research findings will likely benefit society by increasing our understanding of the health benefits of physical activity during pregnancy and how to increase physical activity in previously low-active women. There were no foreseeable risks to either the participants or their babies by participating in this study. Participants may have experienced discomfort from fasting overnight prior to the blood draw at 24-26 weeks gestation and momentary pain during the blood draw. An experienced phlebotomist conducted all blood draws under strict sanitary conditions to minimize pain and risk of infection.

Where is the study run from?
The study was conducted by Iowa State University in collaboration with local obstetric clinics in and around central Iowa (USA).

When is the study starting and how long is it expected to run for?
Recruitment of participants occurred from January to September 2013. Data collection will continue until June 2014.

Who is funding the study?
Funding has been provided by the American Heart Association, Iowa State University College of Human Sciences, and the Sandy S. and Roy W. Uelner Professorship awarded to Dr Christina Campbell.

Who is the main contact?
Professor Christina Campbell
ccampbel@iastate.edu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christina Campbell

ORCID ID

Contact details

220 MacKay Hall
Ames
50011
United States of America
+1 (0)515 294 4260
ccampbel@iastate.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomized controlled trial to evaluate the efficacy of a behaviorally-based website to promote physical activity and prevent excessive gestational weight gain during pregnancy in previously low-active women

Acronym

Study hypothesis

Excessive maternal weight gain during pregnancy affects nearly half of all pregnancies in the United States. A mother is then at risk for developing gestational diabetes and also is more likely to retain her excess weight after she's had the baby. Thus, she begins future pregnancies overweight or obese and again puts herself and her child at risk for several chronic diseases later in life, including type 2 diabetes mellitus and cardiovascular disease. Previous research has suggested that maternal physical activity may reduce the risk of gestational diabetes and excessive gestational weight gain. However, less than 25% of pregnant women meet current prenatal physical activity recommendations. This study will focus on increasing maternal physical activity during pregnancy in order to prevent excessive gestational weight gain.

Hypothesis: Mothers will successfully achieve appropriate pregnancy weight gain relative to pre-pregnancy body mass index (BMI) when given access to an interactive website to increase physical activity that includes goal setting tools and provides social support. Increased self-efficacy will increase adherence to prenatal physical activity recommendations compared to those women who do not have access to these tools. Furthermore, we hypothesize that the infants born to mothers who met current prenatal physical activity and weight gain recommendations will have more favorable body composition and birth outcomes compared to the babies born to mothers that did not meet these recommendations.

Ethics approval

Iowa State University Office for Responsible Research Humans Institutional Review Board (IRB), 11/12/2012, ID#: 11-286

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Excessive maternal weight gain during pregnancy

Intervention

Participants are recruited from obstetric clinics in central Iowa. Randomization is blinded to researchers and participants until after completion of baseline data collection. Participants are randomized to one of two groups:

1. The intervention group, who receive the walking intervention
2. The control group, who receive 'usual care'

An interactive website is used to facilitate the walking-based intervention. Both groups of research participants receive access to the website, but each group has access to different aspects of the website.

Usual care group
Participants randomized to this group have access to a portion of the website that provides information similar to that provided by their medical provider about a healthy diet and physical activity recommendations specific to pregnancy. Women in the usual care group are not asked to make any specific modifications to their current lifestyle (e.g., physical activity and dietary intake).

Intervention group
The participants in this group also have access to the informative aspect of the website as described above; however, they also utilize the interactive portion of the website. Additionally, these participants are asked to walk 30 minutes a day, 5 days a week for a total of 150 minutes of moderately intense walking per week. The interactive website provides individualized goal setting and problem solving modules, self-tracking of physical activity sessions (self-regulation), and social support for participants via interactive social networking with other participants. The website (www.blossomprojectonline.com) aims to increase physical activity among participants by improving self-efficacy, a key construct of the Social-Cognitive Theory. The website is password protected so that users are in control of their own privacy settings and also allows participant website usage to be tracked.

Walking-based intervention
Participants randomized to receive access to the interactive portion of the website begin the walking intervention no later than week 15 of pregnancy. The first four weeks are an acclimation period, designed to slowly increase walking time to reduce discomforts of starting a new physical activity program. By the end of week 18, each participant should be meeting current prenatal physical activity recommendations by walking at least 150 minutes per week or 30 minutes on most, if not all, days of the week. Women are expected to use the self-tracking features of the website to record daily physical activity (self-regulation). The walking intervention lasts until the birth of the baby.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Gestational weight gain was measured at baseline (10-14 weeks gestation), week 22-24 gestation, and week 34-36 gestation. Total gestational weight gain (to the nearest 0.1 kg) was defined as the last weight measured by the research staff between 34-36 weeks gestation minus self-reported pre-pregnancy weight. Pre-pregnancy weight was self-reported at enrollment. Excessive gestational weight gain was defined using the 2009 Institute of Medicine recommendations for total and weekly weight gain recommendations based on maternal pre-pregnancy BMI.
2. Infant body composition: measured at 4 weeks of age via air displacement plethysmography (Pea Pod; Life Measurement Inc., Concord, CA)

Secondary outcome measures

1. Maternal self-efficacy: assessed via validated surveys at baseline (10-14 weeks gestation), week 22-24 gestation, week 34-36 gestation, and 1-month postpartum
2. Maternal adherence to prenatal physical activity recommendations: assessed via objective physical activity monitoring (SenseWear®Mini armband) at baseline (10-14 weeks gestation), week 22-24 gestation, and week 34-36 gestation
3. Maternal insulin resistance: assessed via fasting blood glucose, insulin and a 1-hour 75 g oral glucose tolerance test between 24-26 weeks gestation
4. Infant birth outcomes: birth weight, length, head circumference, and APGAR scores (1 and 5 minutes post-delivery) obtained from the medical birth record

Overall trial start date

01/01/2013

Overall trial end date

01/06/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy pregnant women between the ages of 18-45 years old living in the communities in and around Ames, Iowa with regular internet access
2. All women enrolled in the study are low active, defined as less than three intentional bouts of 30 minutes of moderately intense physical activity per week for at least 6 months prior to conception
3. If asked, women must be willing to walk 30 minutes on most days of the week throughout pregnancy

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

50 women were recruited and enrolled in the study to allow for a 20% attrition rate and ensure 20 participants in each group will complete the study

Participant exclusion criteria

1. Smoking during pregnancy
2. A non-singleton pregnancy
3. A history of chronic disease (e.g., type 1 diabetes, cardiovascular disease, untreated thyroid condition)
4. Any other disease or use of medication known to influence overall metabolism
5. Underweight prior to pregnancy (BMI < 18.5 kg/m2)
6. Inability to communicate due to language or mental status

Recruitment start date

01/01/2013

Recruitment end date

01/09/2013

Locations

Countries of recruitment

United States of America

Trial participating centre

220 MacKay Hall
Ames
50011
United States of America

Sponsor information

Organisation

Individual sponsor (USA)

Sponsor details

Christina Campbell
220 MacKay Hall
Ames
50011
United States of America
+1 (0)515 294 4260
ccampbel@iastate.edu

Sponsor type

Other

Website

Funders

Funder type

Research organisation

Funder name

American Heart Association

Alternative name(s)

American Heart Association, Inc., AHA

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Funder name

Iowa State University College of Human Sciences (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Sandy S. and Roy W. Uelner Professorship (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes