PregnancyNCT01693666
Lifestyle Intervention Forever: Healthy Weight for Pregnancy and Birth (Pilot Study)
A study testing Lifestyle intervention in people with Pregnancy and Obesity, run by St. Louis University at 1 site in United States.
Trial summary
Gaining too much weight in pregnancy is associated with adverse pregnancy complications and can have a long-term impact on maternal and offspring health, including increased risk for obesity and metabolic disease. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Obesity, Weight Gain
- What is being tested?
- Lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-40 years with a confirmed singleton pregnancy of up to 18 weeks gestation
- Pre-pregnancy or early pregnancy BMI greater than or equal to 30 kg/m2
Who cannot join
- Aged < 18 years or > 40 years
- BMI < 30 kg/m2 at study screening
- Multiple gestations
- Previously diagnosed with type 1 or type 2 diabetes mellitus
- Subjects will be excluded from the study if they present with any absolute or relative contraindications to exercise in pregnancy (as defined by ACOG); determined by completion of medical questionnaire by supervising physician
- Any evidence of:
- Drug or alcohol abuse ii. Presence of any unstable psychiatric disorder iii. Plans to move away from the geographical area within the next nine months iv. Other medical or behavioral factors that, in the judgement of the supervising physician, may interfere with their ability to take part in a lifestyle intervention program during pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Gaining too much weight in pregnancy is associated with adverse pregnancy complications and can have a long-term impact on maternal and offspring health, including increased risk for obesity and metabolic disease. Preventing excessive gestational weight gain could reduce adverse pregnancy outcomes and improve long-term health of mothers and offspring. Thirty obese (BMI ≥30) pregnant women will be recruited for this pilot study and randomly assigned to the Lifestyle Intervention ForEver (LIFE) program or routine care (RC). Participants will be enrolled before 18 weeks gestation and will be followed until 12 weeks after delivery. Women in the LIFE program will be given guidance on healthy eating and exercise at their regularly scheduled obstetric visits. To increase adherence to the program, a contingency management (CM) intervention offering incentives will be used to establish and maintain healthy nutrition and physical activity habits, working towards the goal of restricted weight gain (± 10lb) during their pregnancy. Three study testing visits will be scheduled for all participants: at study entry, 34-36 weeks gestation, and 12 weeks after delivering. Primary outcomes include adherence to the LIFE program, weight change in pregnancy and postpartum, and objective measures of maternal and offspring health.
Read the detailed description
The ultimate goal of this research is to examine the impact of a healthy lifestyle intervention, targeting weight gain restriction during pregnancy in obese women (BMI≥30kg/m2), on maternal and fetal outcomes.
The overarching research program has 3 main objectives:
- To establish an effective contingency management behavioral program (LIFE), increasing adherence to nutritional recommendations and exercise guidelines during pregnancy.
- To examine the impact of the LIFE program on weight gain restriction during pregnancy and postpartum weight loss in obese women in comparison to the RC group.
- To examine the impact of the LIFE program on short- and long-term maternal and offspring outcomes at study enrollment, 34-36 weeks gestation and 3 months postpartum in obese women in comparison to the RC group.
- Maternal Outcomes: body composition; peak aerobic capacity; maternal hormonal/metabolic profiles (fasted blood sample); obstetric parameters (incidence of GDM, preeclampsia, cesarean deliveries, obstetric trauma and neonatal complications)
- Offspring Outcomes: fetal growth pattern (fetal ultrasound); neonatal anthropometry assessed ≤ 48 h of birth (crown-heel length, weight, head, chest and waist circumferences, skinfold analyses); metabolic markers at birth (cord blood); and infant anthropometry at 12 weeks of age (as above).
The experimental hypotheses to be tested are that participation in the LIFE intervention in obese pregnant women will prevent excessive weight gain and/or achieve weight maintenance (± 10 lb) during pregnancy and will result in 7-10% weight loss at 12 weeks postpartum. Secondly, we hypothesize that participation in the LIFE intervention in obese pregnant women will be associated with improved aerobic capacity, reduced incidence of obstetric complications and reduced rates of LGA as a result of beneficial alterations to metabolic intrauterine environment for fetal growth.
With regard to this IRB application, we will be conducting a pilot and feasibility trial to address the following specific aims:
- To establish the feasibility of the LIFE program as a large-scale funded project, including participant engagement in the intervention and all study visits.
- To evaluate the feasibility of the LIFE program in achieving weight maintenance and postpartum weight loss targets in obese pregnant women across all three obesity classes.
- To develop and refine the study materials for the LIFE program and assessment battery.
- Conditions
- Pregnancy, Obesity, Weight Gain, Obstetric Complications
- Being tested
- Lifestyle intervention
- Keywords
- Pregnancy, Obesity, Weight gain, Obstetric complications, Lifestyle intervention
- Medical subject headings
- Obesity, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionBehavioural
- To establish an effective contingency management behavioral program (LIFE), increasing adherence to nutritional recommendations and exercise guidelines during pregnancy.
- To examine the impact of the LIFE program on weight gain restriction during pregnancy and postpartum weight loss in obese women in comparison to the RC group.
- To examine the impact of the LIFE program on short- and long-term maternal and offspring outcomes at study enrollment, 34-36 weeks gestation and 3 months postpartum in obese women in comparison to the RC group.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention group | Experimental | The LIFE program emphasizes improved nutritional quality, moderate physical activity, and weight maintenance (±10 lb) in obese pregnant women using a contingency management (CM) approach to reinforce behavior change. Participants will meet with the study dietitian and exercise physiologist every 2-4 weeks to develop and maintain individualized nutrition and physical activity plans, reinforced by CM. When the subject meets with the interventionists at their regular appointments, they will review the diet and exercise requirements, and provide vouchers earned as reinforcement from the previous study period. Diet requirements include at least 5 days of food logs each week. Exercise requirements include objective verification of up to 5 exercise sessions per week (as prescribed). Receives: Behavioral: Lifestyle intervention |
| Routine care group | No intervention | Participants in the Routine Care (RC) control group will receive no additional intervention beyond standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Gestational weight gain from study entry to delivery
Maternal weight (lb) will be measured at program entry and at the time of delivery to determine weight gain during the study period.
Pre-pregnancy body weight will be self-reported and used to estimate total gestational weight gain (lb).
Measured: Approx. 20-25 weeks
Secondary outcomes (15)
Measure Change from baseline in maternal body composition
Changes in lean and fat mass will be examined at study entry, in late pregnancy (34-36 weeks gestation) and at 12 weeks postpartum
Measured: 16-21 weeks
Measure Change from baseline in maternal aerobic capacity
Peak aerobic capacity will be examined via a standard maximal oxygen consumption (VO2max) test performed on a stationary cycle ergometer at study entry, in late pregnancy (34-36 weeks gestation), and at 12 weeks postpartum
Measured: 16-21 weeks
Measure Maternal hormonal/metabolic changes from baseline
A fasted blood sample will be collected at study entry, in late pregnancy (34-36 weeks gestation) and at 12 weeks postpartum to examine changes in lipid profile and adipokines (TNF-alpha, leptin). Fasting glucose, insulin and C-peptide will also be measured and entered into the homeostatic model (HOMA) to estimate changes in insulin sensitivity and beta cell function during the study period.
Measured: 16-21 weeks
Number of participants with Obstetric complications
Parameters examined will include:
- incidence rates of pregnancy complications (gestational diabetes mellitus, preeclampsia, gestational hypertension)
- examination of obstetric parameters (mode of delivery, incidence of obstetric trauma, neonatal complications)
Measured: 1-25 weeks
Change from baseline in maternal dietary intake
Dietary intake will be examined at study entry (15-18 weeks gestation), in late pregnancy (34-36 weeks gestation) and at 12 weeks postpartum.
Measured: 16-21 weeks
Measure Change from baseline in maternal psychometric outcomes
Psychometric outcomes examined at study entry, in late pregnancy (34-36 weeks gestation) and at 12 weeks postpartum include:
- Quality of life
- Depression and mood
- Physical activity social support
- Exercise self-efficacy
Measured: 16-21 weeks
Measure Offspring - fetal growth
Fetal growth and abdominal circumference will be examined by fetal ultrasound at approximately 28-30, 34-36 and 38-40 weeks gestation and/or as part of routine care after 28 weeks gestation.
Measured: 10-25 weeks
Measure Neonatal size at birth
Between group comparisons of birth size will include birth weight (g), crown-heel length (mm), head circumference (mm), body mass index (kg/m2), ponderal index. Population-specific standard deviation (SD) scores will be calculated and the incidence of small for gestational age, appropriate for gestational age and large for gestational age will be compared between groups.
Measured: Within 48 hours of birth
Measure Neonatal body composition at birth
Neonatal lean and fat mass (g) will be calculated based on anthropometric measurements performed within 48 hours after birth
Measured: Within 48 hours of birth
Measure Offspring metabolic markers
Concentrations of insulin-like growth factor (IGF)-I, IGF-II, IGF binding protein-1, IGF binding protein-3, glucose, insulin, leptin and triglyceride will be examined from cord blood samples taken at the time of delivery.
Measured: 20-25 weeks
Measure Pilot study outcomes
The following pilot and feasibility outcomes will be assessed:
- Participant recruitment rate (number of participants recruited per week)
- Participant retention rate (percentage of participants completing all outcomes)
- Adherence to the study program (completion of study data, food records, exercise sessions)
- Success of the study program (percentage of participants achieving target gestational weight gain of plus/minus 10 lb)
- Intervention dose (total intervention time in hours).
Measured: 32-37 weeks
Measure Postpartum weight retention at 12 weeks postpartum
Maternal weight (lb) will be measured at 6 \& 12 weeks postpartum and compared to delivery weight (lb) to determine postpartum weight retention.
Measured: 12 weeks
Measure Change from baseline in maternal physical activity levels
Physical activity levels will be examined at study entry (15-18 weeks gestation), in late pregnancy (34-36 weeks gestation) and at 12 weeks postpartum.
Measured: 16-21 weeks
Measure Infant size at 12 weeks of age
Between group comparisons of body weight (g), length (mm), head circumference (mm), body mass index (kg/m2), and ponderal index. Population-specific SD scores will be calculated and compared between groups.
Measured: 12 weeks
Measure Infant body composition at 12 weeks of age
Infant lean and fat mass (g) will be calculated based on anthropometric measurements performed at 12 weeks of age.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosemary Catanzaro, RD, St. Louis University
- Investigators
- Rosemary Catanzaro, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693666
- Sponsor's protocol ID
- 22009
- Other IDs
- 8485, 22009
- Status last verified
- Sep 2015
- First submitted
- 10 Sep 2012
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention Forever: Healthy Weight for Pregnancy and Birth (Pilot Study)
- ClinicalTrials.gov ID
- NCT01693666
- Acronym / sponsor ID
- 22009
- Conditions
- Pregnancy, Obesity, Weight Gain, Obstetric Complications
- Keywords
- Pregnancy, Obesity, Weight gain, Obstetric complications, Lifestyle intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 26 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gaining too much weight in pregnancy is associated with adverse pregnancy complications and can have a long-term impact on maternal and offspring health, including increased risk for obesity and metabolic disease. Preventing excessive gestational weight gain could reduce adverse pregnancy outcomes and improve long-term health of mothers and offspring. Thirty obese (BMI ≥30) pregnant women will be recruited for this pilot study and randomly assigned to the Lifestyle Intervention ForEver (LIFE) program or routine care (RC). Participants will be enrolled before 18 weeks gestation and will be followed until 12 weeks after delivery. Women in the LIFE program will be given guidance on healthy eating and exercise at their regularly scheduled obstetric visits. To increase adherence to the program, a contingency management (CM) intervention offering incentives will be used to establish and maintain healthy nutrition and physical activity habits, working towards the goal of restricted weight gain (± 10lb) during their pregnancy. Three study testing visits will be scheduled for all participants: at study entry, 34-36 weeks gestation, and 12 weeks after delivering. Primary outcomes include adherence to the LIFE program, weight change in pregnancy and postpartum, and objective measures of maternal and offspring health.
Detailed description
The ultimate goal of this research is to examine the impact of a healthy lifestyle intervention, targeting weight gain restriction during pregnancy in obese women (BMI≥30kg/m2), on maternal and fetal outcomes.
The overarching research program has 3 main objectives:
- To establish an effective contingency management behavioral program (LIFE), increasing adherence to nutritional recommendations and exercise guidelines during pregnancy.
- To examine the impact of the LIFE program on weight gain restriction during pregnancy and postpartum weight loss in obese women in comparison to the RC group.
- To examine the impact of the LIFE program on short- and long-term maternal and offspring outcomes at study enrollment, 34-36 weeks gestation and 3 months postpartum in obese women in comparison to the RC group.
- Maternal Outcomes: body composition; peak aerobic capacity; maternal hormonal/metabolic profiles (fasted blood sample); obstetric parameters (incidence of GDM, preeclampsia, cesarean deliveries, obstetric trauma and neonatal complications)
- Offspring Outcomes: fetal growth pattern (fetal ultrasound); neonatal anthropometry assessed ≤ 48 h of birth (crown-heel length, weight, head, chest and waist circumferences, skinfold analyses); metabolic markers at birth (cord blood); and infant anthropometry at 12 weeks of age (as above).
The experimental hypotheses to be tested are that participation in the LIFE intervention in obese pregnant women will prevent excessive weight gain and/or achieve weight maintenance (± 10 lb) during pregnancy and will result in 7-10% weight loss at 12 weeks postpartum. Secondly, we hypothesize that participation in the LIFE intervention in obese pregnant women will be associated with improved aerobic capacity, reduced incidence of obstetric complications and reduced rates of LGA as a result of beneficial alterations to metabolic intrauterine environment for fetal growth.
With regard to this IRB application, we will be conducting a pilot and feasibility trial to address the following specific aims:
- To establish the feasibility of the LIFE program as a large-scale funded project, including participant engagement in the intervention and all study visits.
- To evaluate the feasibility of the LIFE program in achieving weight maintenance and postpartum weight loss targets in obese pregnant women across all three obesity classes.
- To develop and refine the study materials for the LIFE program and assessment battery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention group | Experimental | Behavioral: Lifestyle interventionThe LIFE program emphasizes improved nutritional quality, moderate physical activity, and weight maintenance (±10 lb) in obese pregnant women using a contingency management (CM) approach to reinforce behavior change. Participants will meet with the study dietitian and exercise physiologist every 2-4 weeks to develop and maintain individualized nutrition and physical activity plans, reinforced by CM. When the subject meets with the interventionists at their regular appointments, they will review the diet and exercise requirements, and provide vouchers earned as reinforcement from the previous study period. Diet requirements include at least 5 days of food logs each week. Exercise requirements include objective verification of up to 5 exercise sessions per week (as prescribed). |
| Routine care group | No intervention | –Participants in the Routine Care (RC) control group will receive no additional intervention beyond standard of care. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women aged 18-40 years with a confirmed singleton pregnancy of up to 18 weeks gestation
- Pre-pregnancy or early pregnancy BMI greater than or equal to 30 kg/m2
Key exclusion criteria (7 listed)
- Aged < 18 years or > 40 years
- BMI < 30 kg/m2 at study screening
- Multiple gestations
- Previously diagnosed with type 1 or type 2 diabetes mellitus
- Subjects will be excluded from the study if they present with any absolute or relative contraindications to exercise in pregnancy (as defined by ACOG); determined by completion of medical questionnaire by supervising physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle intervention1. To establish an effective contingency management behavioral program (LIFE), increasing adherence to nutritional recommendations and exercise guidelines during pregnancy. 2. To examine the impact of the LIFE program on weight gain restriction during pregnancy and postpartum weight loss in obese women in comparison to the RC group. 3. To examine the impact of the LIFE program on short- and long-term maternal and offspring outcomes at study enrollment, 34-36 weeks gestation and 3 months postpartum in obese women in comparison to the RC group. | Behavioural | Lifestyle intervention group |
Primary outcome
Measurement of Gestational weight gain from study entry to delivery
Time frame: Approx. 20-25 weeks
Maternal weight (lb) will be measured at program entry and at the time of delivery to determine weight gain during the study period. Pre-pregnancy body weight will be self-reported and used to estimate total gestational weight gain (lb).
15 secondary outcomes
Measure Change from baseline in maternal body composition
Time frame: 16-21 weeks
Measure Change from baseline in maternal aerobic capacity
Time frame: 16-21 weeks
Measure Maternal hormonal/metabolic changes from baseline
Time frame: 16-21 weeks
Number of participants with Obstetric complications
Time frame: 1-25 weeks
Change from baseline in maternal dietary intake
Time frame: 16-21 weeks
Measure Change from baseline in maternal psychometric outcomes
Time frame: 16-21 weeks
Measure Offspring - fetal growth
Time frame: 10-25 weeks
Measure Neonatal size at birth
Time frame: Within 48 hours of birth
Measure Neonatal body composition at birth
Time frame: Within 48 hours of birth
Measure Offspring metabolic markers
Time frame: 20-25 weeks
Measure Pilot study outcomes
Time frame: 32-37 weeks
Measure Postpartum weight retention at 12 weeks postpartum
Time frame: 12 weeks
Measure Change from baseline in maternal physical activity levels
Time frame: 16-21 weeks
Measure Infant size at 12 weeks of age
Time frame: 12 weeks
Measure Infant body composition at 12 weeks of age
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosemary Catanzaro principal investigator
St. Louis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention in people with Pregnancy and Obesity, run by St. Louis University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Gestational weight gain from study entry to delivery (time frame: Approx. 20-25 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2015.