ObesityNCT02095028
Dietary and Lifestyle Interventions in Obese Pregnant Women
A study testing Dietary and lifestyle intervention in people with Obesity and Weight Gain, run by Capital Medical University at 1 site in China.
Trial summary
Background: Maternal obesity is associated with higher risks of adverse maternal and fetal complications, but the effects of dietary and lifestyle interventions on gestational weight gain(GWG) and pregnancy outcomes in obese pregnant women are unclear. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Obesity, Weight Gain, Lifestyle
- What is being tested?
- Dietary and lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 373 participants
- Where
- 1 siteChina
- Study dates
- Apr 2011to May 2012
- 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
- gestational age between 6 and 12 weeks of gestation, pre-pregnancy≥28 (kg/m2)
- age ≥18 years, and a singleton pregnancy.
Who cannot join
- patients with prediabetes and diabetes, hypertension, chronic renal disease, thyroid disorder
- gestational weeks ≥ 13
- age <18 years
- multiple pregnancy
- uterine malformation
- or physical restriction that prevents exercise.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Obstetrics and Gynecology Hospital,Capital Medical University
Beijing, 100026
About this study
Official title: Effects of Dietary and Lifestyle Interventions in Obese Pregnant Women From the First Trimester on Gestational Weight Gain and Pregnancy Outcomes
Background: Maternal obesity is associated with higher risks of adverse maternal and fetal complications, but the effects of dietary and lifestyle interventions on gestational weight gain(GWG) and pregnancy outcomes in obese pregnant women are unclear.
Objective: This study examined whether intensive dietary and lifestyle interventions initiated in the early pregnancy could decrease GWG, and prevent relevant adverse pregnancy outcomes in Chinese obese pregnant women.
Read more
Design:A randomized controlled trial in obese pregnant women was performed at 6-12 weeks of gestation.The sample size was estimated using GWG reduction as the primary outcome variable. The investigators pilot study (data not published) showed the gestational weight gain was 12.73±5.97 for obese women. Assuming intervention may result in 25% (3.1825g) reduction in GWG, the estimated sample size with 90% power and type I error of 0.05 was 114 women in intervention group and 57 in control group. Adjusting for 15% refusal or loss to follow up during pregnancy, the total sample size required was 136 women in intervention group and 68 in control group(standard care group). Participants were randomly assigned to the control or the intervention group. The intervention focused on restricting energy intake combined with behavioral lifestyle modification through participation in group sessions and individual counseling. The primary outcomes were gestational weight gain (GWG) and secondary outcomes were the incidence of gestational diabetes mellitus (GDM), hypertensive disorders during pregnancy, large-for-gestational-age (LGA) infants, macrosomia and the rate of caesarian section.
Hypothesis:The intensive dietary and lifestyle intervention performed from the first trimester in obese women could decrease total GWG,and perhaps improve relevant pregnancy outcomes.
- Conditions
- Obesity, Weight Gain, Lifestyle, Pregnancy Related
- Being tested
- Dietary and 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.
Dietary and lifestyle interventionBehavioural
participants in the intervention group were provided with an individualized dietary intake protocol. Patients received a diet of not fewer than 1500 calories per day in the first trimester and not fewer than 1800 calories per day after 13wks of gestation.
| Study group | Role | What they receive |
|---|---|---|
| Dietary and lifestyle intervention | Experimental | Intervention group:Based on standard care,intensive dietary and lifestyle intervention was provided. Initiated from the first trimester to delivery,every 2-4 weeks follow-up Receives: Behavioral: Dietary and lifestyle intervention |
| Standard care group | No intervention | Standard care group:Participants received one group session in which prenatal general dietary, nutrition guideline, physical activity and recommendation for gestational weight gain introduced by a registered dietitian in 1.5hours.Participants received their regularly scheduled visits without additional dietary and lifestyle follow-up and guidance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational weight gain
Measured: From enrollment to delivery (28-34 weeks of gestation)
Secondary outcomes (5)
The incidence of gestational diabetes mellitus
Measured: From enrollment to delivery (28-34 weeks of gestation)
The incidence of hypertensive disorders during pregnancy
Measured: From enrollment to delivery (28-34 weeks of gestation)
The incidence of large-for-gestational-age infants
Measured: From enrollment to delivery(28-34 weeks of gestation)
The incidence of macrosomia infants
Measured: From enrollment to delivery (28-34 weeks of gestation)
The rate of caesarian section
Measured: From enrollment to delivery(28-34 weeks of gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startApr 2011
- Primary completionApr 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, China
- Responsible party
- Principal investigator, Guanghui Li, Capital Medical University
- Investigators
- Guanghui Li, MD,PhD, Principal investigator, Beijing Obstetrics and Gynecology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095028
- Sponsor's protocol ID
- 2011-2011-02
- Other IDs
- 201002013
- Status last verified
- Mar 2014
- First submitted
- 19 Mar 2014
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Haslam DW, James WP. Obesity. Lancet. 2005 Oct 1;366(9492):1197-209. doi: 10.1016/S0140-6736(05)67483-1.
PubMed 16198769Heslehurst N, Rankin J, Wilkinson JR, Summerbell CD. A nationally representative study of maternal obesity in England, UK: trends in incidence and demographic inequalities in 619 323 births, 1989-2007. Int J Obes (Lond). 2010 Mar;34(3):420-8. doi: 10.1038/ijo.2009.250. Epub 2009 Dec 22.
PubMed 20029373Stothard KJ, Tennant PW, Bell R, Rankin J. Maternal overweight and obesity and the risk of congenital anomalies: a systematic review and meta-analysis. JAMA. 2009 Feb 11;301(6):636-50. doi: 10.1001/jama.2009.113.
PubMed 19211471Mission JF, Marshall NE, Caughey AB. Obesity in pregnancy: a big problem and getting bigger. Obstet Gynecol Surv. 2013 May;68(5):389-99. doi: 10.1097/OGX.0b013e31828738ce.
PubMed 23624964Oteng-Ntim E, Varma R, Croker H, Poston L, Doyle P. Lifestyle interventions for overweight and obese pregnant women to improve pregnancy outcome: systematic review and meta-analysis. BMC Med. 2012 May 10;10:47. doi: 10.1186/1741-7015-10-47.
PubMed 22574949Thangaratinam S, Rogozinska E, Jolly K, Glinkowski S, Roseboom T, Tomlinson JW, Kunz R, Mol BW, Coomarasamy A, Khan KS. Effects of interventions in pregnancy on maternal weight and obstetric outcomes: meta-analysis of randomised evidence. BMJ. 2012 May 16;344:e2088. doi: 10.1136/bmj.e2088.
PubMed 22596383Guelinckx I, Devlieger R, Mullie P, Vansant G. Effect of lifestyle intervention on dietary habits, physical activity, and gestational weight gain in obese pregnant women: a randomized controlled trial. Am J Clin Nutr. 2010 Feb;91(2):373-80. doi: 10.3945/ajcn.2009.28166. Epub 2009 Dec 2.
PubMed 19955397Phelan S, Phipps MG, Abrams B, Darroch F, Schaffner A, Wing RR. Randomized trial of a behavioral intervention to prevent excessive gestational weight gain: the Fit for Delivery Study. Am J Clin Nutr. 2011 Apr;93(4):772-9. doi: 10.3945/ajcn.110.005306. Epub 2011 Feb 10.
PubMed 21310836Kinnunen TI, Pasanen M, Aittasalo M, Fogelholm M, Hilakivi-Clarke L, Weiderpass E, Luoto R. Preventing excessive weight gain during pregnancy - a controlled trial in primary health care. Eur J Clin Nutr. 2007 Jul;61(7):884-91. doi: 10.1038/sj.ejcn.1602602. Epub 2007 Jan 17.
PubMed 17228348Streuling I, Beyerlein A, von Kries R. Can gestational weight gain be modified by increasing physical activity and diet counseling? A meta-analysis of interventional trials. Am J Clin Nutr. 2010 Oct;92(4):678-87. doi: 10.3945/ajcn.2010.29363. Epub 2010 Jul 28.
PubMed 20668049Nascimento SL, Surita FG, Parpinelli MA, Siani S, Pinto e Silva JL. The effect of an antenatal physical exercise programme on maternal/perinatal outcomes and quality of life in overweight and obese pregnant women: a randomised clinical trial. BJOG. 2011 Nov;118(12):1455-63. doi: 10.1111/j.1471-0528.2011.03084.x. Epub 2011 Sep 6.
PubMed 21895947Connor Gorber S, Tremblay M, Moher D, Gorber B. A comparison of direct vs. self-report measures for assessing height, weight and body mass index: a systematic review. Obes Rev. 2007 Jul;8(4):307-26. doi: 10.1111/j.1467-789X.2007.00347.x.
PubMed 17578381Kiel DW, Dodson EA, Artal R, Boehmer TK, Leet TL. Gestational weight gain and pregnancy outcomes in obese women: how much is enough? Obstet Gynecol. 2007 Oct;110(4):752-8. doi: 10.1097/01.AOG.0000278819.17190.87.
PubMed 17906005Dodd JM, Crowther CA, Robinson JS. Dietary and lifestyle interventions to limit weight gain during pregnancy for obese or overweight women: a systematic review. Acta Obstet Gynecol Scand. 2008;87(7):702-6. doi: 10.1080/00016340802061111.
PubMed 18607830Carreno CA, Clifton RG, Hauth JC, Myatt L, Roberts JM, Spong CY, Varner MW, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Carpenter MW, Sciscione A, Tolosa JE, Saade GR, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Excessive early gestational weight gain and risk of gestational diabetes mellitus in nulliparous women. Obstet Gynecol. 2012 Jun;119(6):1227-33. doi: 10.1097/AOG.0b013e318256cf1a.
PubMed 22617588
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary and Lifestyle Interventions in Obese Pregnant Women From the First Trimester on Gestational Weight Gain and Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT02095028
- Acronym / sponsor ID
- 2011-2011-02
- Conditions
- Obesity, Weight Gain, Lifestyle, Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, China
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 24 Mar 2014 (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.
Background: Maternal obesity is associated with higher risks of adverse maternal and fetal complications, but the effects of dietary and lifestyle interventions on gestational weight gain(GWG) and pregnancy outcomes in obese pregnant women are unclear.
Objective: This study examined whether intensive dietary and lifestyle interventions initiated in the early pregnancy could decrease GWG, and prevent relevant adverse pregnancy outcomes in Chinese obese pregnant women.
Design:A randomized controlled trial in obese pregnant women was performed at 6-12 weeks of gestation.The sample size was estimated using GWG reduction as the primary outcome variable. The investigators pilot study (data not published) showed the gestational weight gain was 12.73±5.97 for obese women. Assuming intervention may result in 25% (3.1825g) reduction in GWG, the estimated sample size with 90% power and type I error of 0.05 was 114 women in intervention group and 57 in control group. Adjusting for 15% refusal or loss to follow up during pregnancy, the total sample size required was 136 women in intervention group and 68 in control group(standard care group). Participants were randomly assigned to the control or the intervention group. The intervention focused on restricting energy intake combined with behavioral lifestyle modification through participation in group sessions and individual counseling. The primary outcomes were gestational weight gain (GWG) and secondary outcomes were the incidence of gestational diabetes mellitus (GDM), hypertensive disorders during pregnancy, large-for-gestational-age (LGA) infants, macrosomia and the rate of caesarian section.
Hypothesis:The intensive dietary and lifestyle intervention performed from the first trimester in obese women could decrease total GWG,and perhaps improve relevant pregnancy outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary and lifestyle intervention | Experimental | Behavioral: Dietary and lifestyle interventionIntervention group:Based on standard care,intensive dietary and lifestyle intervention was provided. Initiated from the first trimester to delivery,every 2-4 weeks follow-up |
| Standard care group | No intervention | –Standard care group:Participants received one group session in which prenatal general dietary, nutrition guideline, physical activity and recommendation for gestational weight gain introduced by a registered dietitian in 1.5hours.Participants received their regularly scheduled visits without additional dietary and lifestyle follow-up and guidance. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- gestational age between 6 and 12 weeks of gestation, pre-pregnancy≥28 (kg/m2)
- age ≥18 years, and a singleton pregnancy.
Key exclusion criteria (6 listed)
- patients with prediabetes and diabetes, hypertension, chronic renal disease, thyroid disorder
- gestational weeks ≥ 13
- age <18 years
- multiple pregnancy
- uterine malformation
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 |
|---|---|---|
| Dietary and lifestyle interventionparticipants in the intervention group were provided with an individualized dietary intake protocol. Patients received a diet of not fewer than 1500 calories per day in the first trimester and not fewer than 1800 calories per day after 13wks of gestation. | Behavioural | Dietary and lifestyle intervention |
Primary outcome
Gestational weight gain
Time frame: From enrollment to delivery (28-34 weeks of gestation)
5 secondary outcomes
The incidence of gestational diabetes mellitus
Time frame: From enrollment to delivery (28-34 weeks of gestation)
The incidence of hypertensive disorders during pregnancy
Time frame: From enrollment to delivery (28-34 weeks of gestation)
The incidence of large-for-gestational-age infants
Time frame: From enrollment to delivery(28-34 weeks of gestation)
The incidence of macrosomia infants
Time frame: From enrollment to delivery (28-34 weeks of gestation)
The rate of caesarian section
Time frame: From enrollment to delivery(28-34 weeks of gestation)
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 24 Mar 2014.
- Background: PubMed 16198769Haslam DW, James WP. Obesity. Lancet. 2005 Oct 1;366(9492):1197-209. doi: 10.1016/S0140-6736(05)67483-1.
- Background: PubMed 20029373Heslehurst N, Rankin J, Wilkinson JR, Summerbell CD. A nationally representative study of maternal obesity in England, UK: trends in incidence and demographic inequalities in 619 323 births, 1989-2007. Int J Obes (Lond). 2010 Mar;34(3):420-8. doi: 10.1038/ijo.2009.250. Epub 2009 Dec 22.
- Background: PubMed 19211471Stothard KJ, Tennant PW, Bell R, Rankin J. Maternal overweight and obesity and the risk of congenital anomalies: a systematic review and meta-analysis. JAMA. 2009 Feb 11;301(6):636-50. doi: 10.1001/jama.2009.113.
- Background: PubMed 23624964Mission JF, Marshall NE, Caughey AB. Obesity in pregnancy: a big problem and getting bigger. Obstet Gynecol Surv. 2013 May;68(5):389-99. doi: 10.1097/OGX.0b013e31828738ce.
- Background: PubMed 22574949Oteng-Ntim E, Varma R, Croker H, Poston L, Doyle P. Lifestyle interventions for overweight and obese pregnant women to improve pregnancy outcome: systematic review and meta-analysis. BMC Med. 2012 May 10;10:47. doi: 10.1186/1741-7015-10-47.
- Background: PubMed 22596383Thangaratinam S, Rogozinska E, Jolly K, Glinkowski S, Roseboom T, Tomlinson JW, Kunz R, Mol BW, Coomarasamy A, Khan KS. Effects of interventions in pregnancy on maternal weight and obstetric outcomes: meta-analysis of randomised evidence. BMJ. 2012 May 16;344:e2088. doi: 10.1136/bmj.e2088.
- Background: PubMed 19955397Guelinckx I, Devlieger R, Mullie P, Vansant G. Effect of lifestyle intervention on dietary habits, physical activity, and gestational weight gain in obese pregnant women: a randomized controlled trial. Am J Clin Nutr. 2010 Feb;91(2):373-80. doi: 10.3945/ajcn.2009.28166. Epub 2009 Dec 2.
- Background: PubMed 21310836Phelan S, Phipps MG, Abrams B, Darroch F, Schaffner A, Wing RR. Randomized trial of a behavioral intervention to prevent excessive gestational weight gain: the Fit for Delivery Study. Am J Clin Nutr. 2011 Apr;93(4):772-9. doi: 10.3945/ajcn.110.005306. Epub 2011 Feb 10.
- Background: PubMed 17228348Kinnunen TI, Pasanen M, Aittasalo M, Fogelholm M, Hilakivi-Clarke L, Weiderpass E, Luoto R. Preventing excessive weight gain during pregnancy - a controlled trial in primary health care. Eur J Clin Nutr. 2007 Jul;61(7):884-91. doi: 10.1038/sj.ejcn.1602602. Epub 2007 Jan 17.
- Background: PubMed 20668049Streuling I, Beyerlein A, von Kries R. Can gestational weight gain be modified by increasing physical activity and diet counseling? A meta-analysis of interventional trials. Am J Clin Nutr. 2010 Oct;92(4):678-87. doi: 10.3945/ajcn.2010.29363. Epub 2010 Jul 28.
- Background: PubMed 21895947Nascimento SL, Surita FG, Parpinelli MA, Siani S, Pinto e Silva JL. The effect of an antenatal physical exercise programme on maternal/perinatal outcomes and quality of life in overweight and obese pregnant women: a randomised clinical trial. BJOG. 2011 Nov;118(12):1455-63. doi: 10.1111/j.1471-0528.2011.03084.x. Epub 2011 Sep 6.
- Background: PubMed 17578381Connor Gorber S, Tremblay M, Moher D, Gorber B. A comparison of direct vs. self-report measures for assessing height, weight and body mass index: a systematic review. Obes Rev. 2007 Jul;8(4):307-26. doi: 10.1111/j.1467-789X.2007.00347.x.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Guanghui Li, MD,PhD principal investigator
Beijing Obstetrics and Gynecology Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary and lifestyle intervention in people with Obesity and Weight Gain, run by Capital Medical University at 1 site in China.
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 6 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 24 Mar 2014. 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 China. 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?
Gestational weight gain (time frame: From enrollment to delivery (28-34 weeks of gestation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02095028, which also lists 20 linked publications.
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 24 Mar 2014.