Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02168647 |
| Other study ID # |
14-199 |
| Secondary ID |
14-199 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
June 18, 2014 |
| Last updated |
March 17, 2018 |
| Start date |
March 2015 |
| Est. completion date |
October 2017 |
Study information
| Verified date |
March 2018 |
| Source |
Iowa State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Multiple studies have demonstrated a very low prevalence of women meeting physical activity
and weight gain recommendations during pregnancy. The aim of this study is to provide a
lifestyle intervention to increase physical activity, reduce carbohydrate intake, prevent
excessive gestational weight gain, decrease postpartum weight retention, and improve mental
well-being compared to "usual care" using a randomized controlled design in pregnant women.
Participants in the intervention group will receive behavioral lifestyle counseling and take
part in monthly one-on-one visits with a registered dietitian (RDN) from approximately week
14 of their pregnancy to child birth. Participants in the "usual care" group (control) will
not receive any lifestyle counseling. Data collected from this group will be used to compare
the effectiveness of the lifestyle intervention. Unlike many studies examining diet and
physical activity factors alone, this study evaluates additional psychosocial factors such as
psychological health, self-efficacy, competence, motivation and barriers that may influence
excessive gestational weight gain. In addition, the Self-Determination Theory framework will
be used to measure how motivation and motivational interviewing strategies can help explain
changes in volitional behavior.
Description:
Pregnant women will be recruited using mass email recruitment, fliers posted at local
community settings, and at local OBGYN offices in Ames,IA. Pregnant women will be recruited
prior to their 14th week of gestation. Interested individuals will contact the Blossom
Project staff for further information.
A randomized controlled design will be used. Following baseline data collection, women will
be randomized into the intervention group (n=30) or control (n=30).
For this study, the goal is to have a total of 30 women in the intervention group and 30 in
the control. With an attrition rate of 20% investigators plan to enroll 37 women per group.
Furthermore, increased enrollment numbers will cover inconsistencies that may arise with
missing or uninterpretable data.
Individuals who contact the Blossom Project will be screened for eligibility. Individuals
that meet the inclusion and exclusion criteria will meet with a Blossom Project staff member
to sign an informed consent form approved by the Iowa State University Institutional Review
Board (ISU-IRB). A "medical consent form" (not the consent form for the study participant)
will be sent to the woman's primary obstetric provider asking to confirm qualification
criteria. Participants will then be asked to complete a medical history questionnaire.
Eligible participants will be asked to complete a maximum of four data collection periods.
Participants will report to the Nutrition Wellness Research Center (NWRC) either on campus
(HNSB 2021, 2022, 2023) or the facility located at 2325 North Loop Drive, Suite 6100, Ames,
Iowa 50010, at the beginning and end of each of the four data collection periods. A "visit"
or "data collection period" is defined as 8 days. There are 3 data collection periods during
pregnancy (visits 1-3) and one post-partum visit (visit 4). Visit 4 is not an 8-day data
collection period and will take no more than 90 minutes at the NWRC.
Data that will be collected during each of the data collection periods will include:
Visit 1: Prior to 14-weeks of pregnancy (8-14 weeks):
- Consent form: Participants will meet with a staff member to discuss the consent form and
requirements of the study. Signed informed consent will be obtained from each
participant.
- Medical provider consent: Medical providers will confirm qualification criteria for each
participant. The medical provider consent must be received prior to a woman beginning
the walking program (intervention group). Participants will sign this form at visit 1 to
grant Blossom Project staff the permission to contact their medical provider.
- Medical history questionnaire: Each participant will fill out a medical history
questionnaire.
- Physical activity assessment: Participants will receive verbal and written instructions
on how to collect data regarding their physical activity. Each participant will wear 2
activity monitors to assess physical activity patterns over the 8-day monitoring period
at weeks 8-14, 26-28 and 34-36 of their pregnancy. The sensors will be worn on the left
arm over the triceps muscle (SenseWear Mini armband) and on the right leg over the
quadriceps muscle (activPAL). All of these monitors have been used in our previous
pregnancy studies with minimal complaints. Participants are required to record all their
daily activities in a physical activity log that will be provided. The log is required
to be recorded over the same consecutive 8 days for 24 hours a day that the 2 activity
monitors are worn.
- Dietary assessment: Participants will receive verbal instructions on how to collect data
regarding their dietary intake. Each woman will complete a 3-day weighed diet record
which requires her to weigh and record all food and beverages consumed for 2 weekdays
and 1 weekend day. Detailed written instructions will also be provided in a binder in a
data collection bag with a dietary scale.
- Mental Well-being: Participants will complete the World Health Organization Quality of
Life questionnaire that measures physical health, psychological health, social
relationships and environment, the Edinburg Postnatal Depression Scale, which has been
used for non-postnatal women as well as a screening scale for depression (pre-testing
for our study), and a battery of standardized questionnaires regarding perceived
self-efficacy, competence, motivation and barriers to control weight gain during
pregnancy, and exercise safety beliefs. It should take approximately 15 minutes at each
visit to complete these surveys.
- Anthropometric measurements: Height and weight will be measured. Body composition will
be assessed using the BodPod, an air displacement plethysmograph that uses whole body
densitometry to determine body composition using body mass and volume measures. We have
used this technique in previous Blossom Project studies.
- Scheduling of follow-up appointment: Participants will schedule a time to return to the
research facility the following week to return all monitors and materials (diet record,
data collection bag, dietary scale).
- At enrollment, participants will fill out a Release of Medical Record form for their
delivering hospital, to allow a Blossom Project staff member the ability to attain birth
weight, birth length, head circumference, and APGAR scores at 1- and 5-minutes after the
child is born utilizing medical records.
Visit 2 (weeks 26-28):
- Physical activity assessment via two monitors: SenseWear armband and the activPAL
- 3-day weighed diet record
- The same battery of the psychological variables (as described earlier) will be measured
during this period. In addition a motivational interviewing fidelity checklist will be
collected (through observations of the counseling sessions and self-reports from the
counselor) to ensure that the motivational interviewing strategies were implemented.
- Anthropometric measurements: Weight 2-hour Oral Glucose Tolerance Test: The oral glucose
tolerance test will consist of providing a fasted blood sample (following an overnight
fast of 10-12 hours), consuming a 75-gram oral glucose solution and a blood sample at 60
minutes and 120 minutes following the consumption of the glucose solution. During this
2-hour period, the participant will be asked to remain seated at the research facility.
The blood draw will be conducted by an experienced phlebotomist.
Visit 3 (weeks 34-36)
- Physical activity assessment via two monitors: SenseWear armband and the activPAL
- 3-day weighed diet record
- Measure of psychological variables (as described earlier) will be measured and a
motivational fidelity checklist (as described in visit 2). During this visit, perceived
support using the Health Care Climate questionnaire and psychological need satisfaction,
using the Activity Feeling Scale, will be used to measure whether an autonomy supportive
climate during the individualized lifestyle counseling was established for the
intervention group.
- Anthropometric measurements: Weight
Visit 4 (2 months post-partum):
- Anthropometric measurements: Weight and maternal body composition using the BodPod.
- Infant Outcomes: birth outcomes; body composition using the PeaPod, air displacement
plethysmograph used to assess infant body composition. The infant will be placed in a
temperature-controlled test chamber of the PeaPod with a continuous outside air source
for a brief amount of time (approximately one minute or less) while the measurement is
taking place.
- Mental well-being: The Quality of Life scale, the postpartum depression scale and the
perceived motivation and self-efficacy to continue to be physically active will be
measured.
In order to protect the privacy of participants within the study records identifying
participants will be kept confidential to the extent allowed by applicable laws and
regulations. Records will not be made publicly available. To ensure confidentiality to the
extent allowed by law, the following measures will be taken. Participants will be assigned a
unique code that will be used on forms instead of their name. The signed consent form,
medical provider consent form, and release of medical information forms will all need the
woman's full name to identify her to her prenatal clinic and delivering hospital. These forms
will be locked in a separate filing cabinet from the forms with the participant codes to
prevent identification of the participants. If the results are published, the identity will
remain confidential. The data obtained from the study will be regarded as privileged and
confidential. The privacy will be maintained in any future analysis and/or presentation of
the data with the use of coded identifications for each participant's data.Only members of
the Blossom Project lab staff will have access to the data and study records. All data will
be stored in a locked file cabinet with access only by the principal investigator and project
staff. This data will be kept on hand in a separate locked file in the PI's laboratory (HNSB
1109, Iowa State University) until the results of the study have been published. Identifiers
will be kept separate from the data. All electronic data is stored on a shared drive only
accessible to the principal investigator and project staff which requires a password to
access.
For statistical analysis data will be presented as descriptive variables. These variables
will consist of diet, physical activity characteristics, adherence to daily step count
recommendations, and postpartum outcomes. Between group differences, time effects, and
corresponding interactions in the above variables will be assessed by a series of two-way
analysis of variance contrasts. When identified, such differences will be further explored,
in terms of relationships to the other measured characteristics of the study groups via
correlations and regression-based modeling procedures. Statistical significance will be set
at p < 0.05 and adjusted for any multiple comparisons.
