Overweight and ObesityNCT01643356
Interventions to Reduce Excess Weight Gain in Pregnancy
A study testing Intervention to reduce excess weight gain during pregnancy in people with Overweight and Obesity and Pregnancy, run by Tufts University at 2 sites in United States.
Trial summary
The study will use a comprehensive behavioral intervention adapted for pregnant women to change dietary intake, eating behavior and physical activity. The central hypothesis of this study is that the intervention will reduce excess gestational weight gain and achieve clinical and metabolic benefits in obese and… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Overweight and Obesity, Pregnancy
- What is being tested?
- Intervention to reduce excess weight gain during pregnancy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2012to Sep 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-45 years
- In first trimester of pregnancy
- Must be willing to not join any other weight control program while in the study
- BMI of 25-40 kg/m2
- Willingness and ability to attend support group meetings either in person or via web
- Must be able to read, speak, and understand English
Who cannot join
- Carrying multiple fetuses
- Gestational diabetes mellitus at study entry
- Type 2 diabetes mellitus or blood glucose >125 mg/dl at screening
- Self reported current substance abuse
- Current smoking
- Alchol consumption of more than 1 drink per day
Show all 10Show fewer
- Preexisting medical conditions (includes bariatric surgery) or use of medications that would impact study involvement or outcomes testing
- Eating disorder in the past 2 years
- Depression or diagnosis of bipolar disorder
- Concurrent participation in any other research study that would impact participation in this investigation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Tufts University Human Nutrition Research Center on Aging
Boston, Massachusetts, 02111
About this study
Official title: Interventions to Reduce Excess Weight Gain in Pregnancy in Overweight and Obese Mothers
The study will use a comprehensive behavioral intervention adapted for pregnant women to change dietary intake, eating behavior and physical activity. The central hypothesis of this study is that the intervention will reduce excess gestational weight gain and achieve clinical and metabolic benefits in obese and overweight pregnant women and their infants over the first year of life.
- Conditions
- Overweight and Obesity, Pregnancy
- Being tested
- Intervention to reduce excess weight gain during pregnancy
- Keywords
- weight, pregnancy, behavioral intervention, obesity
- Medical subject headings
- Overweight, Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention to reduce excess weight gain during pregnancyBehavioural
Intervention includes meetings with a nutrition counselor and/or psychologist where individualized eating plans will be developed and reviewed, and regular group meetings during which information about healthy eating for weight management will be discussed.
| Study group | Role | What they receive |
|---|---|---|
| Fiber Cereal | Active comparator | Women assigned to this arm will receive the group based behavioral intervention plus the recommendation to consume provided high fiber cereal to manage hunger. Receives: Behavioral: Intervention to reduce excess weight gain during pregnancy |
| Control Group | No intervention | Women assigned to this arm of the study will receive routine clinical care and no additional interventions. |
| Resistant Starch | Active comparator | Women assigned to this arm will receive the group based behavioral intervention plus the recommendation to consume provided resistant starch to control hunger Receives: Behavioral: Intervention to reduce excess weight gain during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal and Infant Body Weight Change
- Maternal non-fasting weight measured at all prenatal clinic and study visits.
- Infant weight measured at birth and all pediatric clinic visits through 1 year.
Measured: From first trimester through 1 year post-partum
Secondary outcomes (2)
Infant Outcomes
- Body composition (i.e. length, head circumference, skinfold thickness, waist circumference) changes through the first year.
- Characteristics at birth including Apgar score, gestational age.
- Dietary intake and food preferences at 1 year.
Measured: From birth through first year
Maternal and Perinatal Outcomes
- Rates of cesarean delivery, gestational hypertension/preeclampsia, preterm birth, birth complications.
- Fasting blood glucose and insulin concentrations throughout pregnancy.
- Body composition and energy requirements at baseline and 24-28 weeks of pregnancy.
- Total energy expenditure at 24-28 weeks of pregnancy.
- Rate of breastfeeding and breastfeeding practices at 1, 3, 6, and 12 months post-partum.
Measured: First trimester through 1 year post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Roberts, Tufts University
- Investigators
- Susan B Roberts, Ph.D., Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643356
- Sponsor's protocol ID
- 10203 Tufts
- Status last verified
- May 2016
- First submitted
- 16 Jul 2012
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Reduce Excess Weight Gain in Pregnancy in Overweight and Obese Mothers
- ClinicalTrials.gov ID
- NCT01643356
- Acronym / sponsor ID
- 10203 Tufts
- Conditions
- Overweight and Obesity, Pregnancy
- Keywords
- weight, pregnancy, behavioral intervention, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 Jul 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.
The study will use a comprehensive behavioral intervention adapted for pregnant women to change dietary intake, eating behavior and physical activity. The central hypothesis of this study is that the intervention will reduce excess gestational weight gain and achieve clinical and metabolic benefits in obese and overweight pregnant women and their infants over the first year of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fiber Cereal | Active comparator | Behavioral: Intervention to reduce excess weight gain during pregnancyWomen assigned to this arm will receive the group based behavioral intervention plus the recommendation to consume provided high fiber cereal to manage hunger. |
| Control Group | No intervention | –Women assigned to this arm of the study will receive routine clinical care and no additional interventions. |
| Resistant Starch | Active comparator | Behavioral: Intervention to reduce excess weight gain during pregnancyWomen assigned to this arm will receive the group based behavioral intervention plus the recommendation to consume provided resistant starch to control hunger |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-45 years
- In first trimester of pregnancy
- Must be willing to not join any other weight control program while in the study
- BMI of 25-40 kg/m2
- Willingness and ability to attend support group meetings either in person or via web
Key exclusion criteria (10 listed)
- Carrying multiple fetuses
- Gestational diabetes mellitus at study entry
- Type 2 diabetes mellitus or blood glucose >125 mg/dl at screening
- Self reported current substance abuse
- Current smoking
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 |
|---|---|---|
| Intervention to reduce excess weight gain during pregnancyIntervention includes meetings with a nutrition counselor and/or psychologist where individualized eating plans will be developed and reviewed, and regular group meetings during which information about healthy eating for weight management will be discussed. | Behavioural | Fiber Cereal, Resistant Starch |
Primary outcome
Maternal and Infant Body Weight Change
Time frame: From first trimester through 1 year post-partum
* Maternal non-fasting weight measured at all prenatal clinic and study visits. * Infant weight measured at birth and all pediatric clinic visits through 1 year.
2 secondary outcomes
Infant Outcomes
Time frame: From birth through first year
Maternal and Perinatal Outcomes
Time frame: First trimester through 1 year post-partum
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 10 May 2016.
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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.
Susan B Roberts, Ph.D. principal investigator
Tufts University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention to reduce excess weight gain during pregnancy in people with Overweight and Obesity and Pregnancy, run by Tufts University at 2 sites 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 6 inclusion and 10 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 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Maternal and Infant Body Weight Change (time frame: From first trimester through 1 year post-partum). 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 10 May 2016; AzTrials last refreshed its copy on 1 Nov 2026.