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Randomized trial of a behavioral intervention to prevent excessive gestational weight gain: the Fit for Delivery Study.

ABSTRACT: Excessive weight gain during pregnancy is a major risk factor for postpartum weight retention and future weight gain and obesity in women, but few adequately powered randomized controlled trials have examined the efficacy of a behavioral weight-control intervention during pregnancy.This study examined whether a behavioral intervention during pregnancy could decrease the proportion of women who exceeded the 1990 Institute of Medicine (IOM) recommendations for gestational weight gains and increase the proportion of women who returned to pregravid weights by 6 mo postpartum.This study was a randomized, assessor-blind, controlled trial. Participants were pregnant (13.5 wk gestation), normal-weight (NW; n = 201) and overweight or obese (OW/OB; n = 200) women whose average age was 28.8 y. Participants were randomly assigned within the 1990 IOM weight category (NW compared with OW/OB) to standard care (n = 200) or to a behavioral intervention to prevent excessive gestational weight gain (n = 201). The intervention included one face-to-face visit; weekly mailed materials that promoted an appropriate weight gain, healthy eating, and exercise; individual graphs of weight gain; and telephone-based feedback. The retention at the 6-mo postpartum assessment was 82%.Intent-to-treat analyses showed that the intervention, compared with standard care, decreased the percentage of NW women who exceeded IOM recommendations (40.2% compared with 52.1%; P = 0.003) and increased the percentages of NW and OW/OB women who returned to their pregravid weights or below by 6 mo postpartum (30.7% compared with 18.7%; P = 0.005).A low-intensity behavioral intervention during pregnancy reduced excessive gestational weight gains in NW women and prevented postpartum weight retention in NW and OW/OB women. This trial was registered at clinicaltrials.gov as NCT01117961.

SUBMITTER: Phelan S

PROVIDER: S-EPMC3057546 | biostudies-literature | 2011 Apr

REPOSITORIES: biostudies-literature

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Randomized trial of a behavioral intervention to prevent excessive gestational weight gain: the Fit for Delivery Study.

Phelan Suzanne S Phipps Maureen G MG Abrams Barbara B Darroch Francine F Schaffner Andrew A Wing Rena R RR

The American journal of clinical nutrition 20110210 4

<h4>Background</h4>Excessive weight gain during pregnancy is a major risk factor for postpartum weight retention and future weight gain and obesity in women, but few adequately powered randomized controlled trials have examined the efficacy of a behavioral weight-control intervention during pregnancy.<h4>Objective</h4>This study examined whether a behavioral intervention during pregnancy could decrease the proportion of women who exceeded the 1990 Institute of Medicine (IOM) recommendations for ...[more]

PMID: 21310836

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Project description:BackgroundBehavioral lifestyle interventions during pregnancy can prevent excessive gestational weight gain (GWG) in women with normal weight; however, effective interventions to reduce GWG in ethnically diverse women with obesity are lacking.ObjectiveA randomized controlled trial was conducted to test whether a behavioral lifestyle intervention with partial meal replacement reduces GWG rate in Hispanic and non-Hispanic women with overweight or obesity relative to enhanced usual care.DesignParticipants (n = 257) were recruited in San Luis Obispo, California, and Providence, Rhode Island, between November 2012 and May 2016. Participants were pregnant (mean ± SD: 13.6 ± 1.8 wk of gestation) with overweight or obesity and had a mean age of 30.3 y; 41.6% of participants were Hispanic. Women were randomly assigned within site and by ethnicity to enhanced usual care (n = 128) or to a behavioral lifestyle intervention with partial meal replacement (n = 129). The primary outcome was GWG per week of observation. Secondary outcomes were proportions exceeding Institute of Medicine (IOM) guidelines for total GWG, changes in weight-control behaviors and cardiovascular disease risk factors, and incidence of pregnancy complications. Study retention was 99.6% (256 of 257).ResultsThe intervention compared with usual care resulted in less mean ± SD weekly GWG (0.33 ± 0.25 compared with 0.39 ± 0.23 kg/wk; P = 0.02) and total GWG (9.4 ± 6.9 compared with 11.2 ± 7.0 kg; P = 0.03) and reduced the proportion of women who exceeded IOM guidelines for total GWG (41.1% compared with 53.9%; P = 0.03). No significant group × time × demographic subgroup (ethnicity, BMI, age, parity, and income) interactions were observed. Among intervention participants, greater meal replacement intake was related to reduced GWG rate (β = -0.07; 95% CI:-0.12, -0.03; P = 0.002). The intervention compared with usual care increased weight-control strategies (P < 0.0001) and cognitive restraint (P < 0.0001) and reduced triglycerides (P = 0.03).ConclusionPrenatal behavioral intervention with partial meal replacement significantly reduced GWG in Hispanic and non-Hispanic women with overweight or obesity. This trial was registered at www.clinicaltrials.gov as NCT01545934.

Project description:BackgroundOnline interventions have emerged as a popular strategy to promote healthy behaviors. Currently, there is little agreement about how to capture online intervention engagement. It is also uncertain who engages with weight-related online interventions and how engagement differs by demographic and weight characteristics.ObjectiveThe objectives of this study were to (1) characterize how pregnant women engaged with features of an online intervention to prevent excessive gestational weight gain, (2) identify demographic and weight status subgroups of women within the sample, and (3) examine differences in use of intervention features across the demographic and weight status subgroups.MethodsA sample of racially and socioeconomically diverse pregnant women from a northeastern US city was assigned to the intervention group in a randomized controlled trial to prevent excessive gestational weight gain (n=1014). The intervention website included these features: weight-gain tracker, health-related articles, blogs, physical activity and diet goal-setting tools, and local resources. Engagement variables were created to capture the amount, consistency, and patterns of feature use across pregnancy using latent class analysis. Demographic/weight status subgroups were also created using latent class analysis. Differences in engagement across the demographic/weight status subgroups were examined using chi-square analysis.ResultsSix engagement patterns emerged: "super-users" (13.02%, 132/1014), "medium-users" (14.00%, 142/1014), "consistent weight-tracker users" (14.99%, 152/1014); "almost consistent weight-tracker users" (21.99%, 223/1014), "inconsistent weight-tracker users" (15.98%, 162/1014), and "non-users" (20.02%, 203/1014). Four demographic/weight status subgroups emerged: three minority and one white. There were different engagement patterns by demographic/weight status subgroups. Super-users were more likely to be in the white subgroup, while non-users were more likely to be in the minority subgroups. However, around a third of women in minority subgroups were consistently or almost consistently engaging with the weight-tracker (black, young women, 32.2%, 67/208; black, heavier women, 37.9%, 50/132; Hispanic women, 27.4%, 32/117).ConclusionsWhile white and higher income women had higher engagement in general, depending on the measure, there was still considerable engagement by the minority and low-income women.Trial registrationClinicaltrials.gov: NCT01331564; http://clinicaltrials.gov/ct2/show/NCT01331564 (Archived by WebCite at http://www.webcitation.org/6Rw4yKxI5).

Project description:It is unclear whether weight management is still effective for pregnant women with excessive weight gain in the second or third trimester in China. This study adopted individualized weight management intervention for pregnant women with abnormal weight gain in the second or third trimester, to analyze the effect of intervention by observing the gestational weight gain and perinatal outcomes. This randomized controlled trial was performed at Aerospace Center Hospital. The obstetrician determined whether the pregnant women gained too much weight in the second or third trimester according to the Institute of Medicine guidelines, and randomly divided the pregnant women who gained too much weight in the second or third trimester into the intervention group or the control group according to the inclusion and exclusion criteria. The pregnant women in the intervention group and in the control group all received routine prenatal examination and diet nutrition education by the doctors in the Department of Obstetrics and Gynecology. The intervention group underwent individualized weight management, including individualized diet, exercise, psychological assessment, cognitive intervention and continuous communication, the whole process is tracked and managed by professional nutritionists. The obstetrician collected the prenatal examination data and pregnancy outcome data of all enrolled pregnant women. The primary outcome measure was weight gain during pregnancy. A generalized linear model and a logistic regression model were used to compare the outcomes between the two groups. In total, 348 pregnant women participated in this study with 203 in the intervention group and 145 in the control group. The whole gestational weight gain in the intervention group (15.8 ± 5.4 Kg) was lower than that in the control group (17.5 ± 3.6 Kg; adjusted β = - 1.644; 95% CI [-2.660--0.627]; P = 0.002). The percent of pregnant women with excessive weight gainbefore delivery was 54.2% (110/203) in the intervention group, which was lower than 69.7% (101/145) in the control group (adjusted RR = 0.468; 95% CI [0.284-0.769] P = 0.003). The pregnant women given the individualized weight management intervention from the second to the third trimester experienced less weight gain than that from the third trimester (15.5 ± 5.6 Kg vs. 16.2 ± 5.2 Kg), but without significant difference (P = 0.338). Lower rates of GDM, preeclampsia and gestational hypertension, higher rates of fetal distress and puerperal infection were observed in the intervention group than in the control group (all P < 0.05). Individualized weight management during the second or third trimesters is still beneficial for pregnant women who gain excessive weight and can decrease the associated adverse outcomes.

Project description:BACKGROUND:Excessive gestational weight gain (GWG) leads to obstetric complications, maternal postpartum weight retention and an increased risk of offspring obesity. The GeliS study examines the effect of a lifestyle intervention during pregnancy on the proportion of women with excessive GWG and pregnancy and obstetric complications, as well as the long-term risk of maternal and infant obesity. METHODS:The GeliS study is a cluster-randomised multicentre controlled trial including 2286 women with a pre-pregnancy BMI between 18.5 and 40.0 kg/m2 recruited from gynaecological and midwifery practices prior to the end of the 12th week of gestation in five Bavarian regions. In the intervention regions, four lifestyle counselling sessions covering a balanced healthy diet, regular physical activity and self-monitoring of weight gain were performed by trained healthcare providers alongside routine pre- and postnatal practice visits. In the control regions, leaflets with general recommendations for a healthy lifestyle during pregnancy were provided. RESULTS:The intervention did not result in a significant reduction of women showing excessive GWG (adjusted OR 0.95, 95% CI 0.66-1.38, p = 0.789), with 45.1% and 45.7% of women in the intervention and control groups, respectively, gaining weight above the Institute of Medicine recommendations. Gestational diabetes mellitus was diagnosed in 10.8% and 11.1% of women in the intervention and control groups, respectively (p = 0.622). Mean birth weight and length were slightly lower in the intervention group (3313 ± 536 g vs. 3363 ± 498 g, p = 0.020; 51.1 ± 2.7 cm vs. 51.6 ± 2.5 cm, p = 0.001). CONCLUSION:In the setting of routine prenatal care, lifestyle advice given by trained healthcare providers was not successful in limiting GWG and pregnancy complications. Nevertheless, the potential long-term effects of the intervention remain to be assessed. TRIAL REGISTRATION:NCT01958307 , ClinicalTrials.gov, retrospectively registered October 9, 2013.

Project description:BackgroundExcessive gestational weight gain (GWG) is common and contributes to the development of obesity in women and their offspring. Electronic or e-health interventions have the potential to reach large groups of women and prevent excessive GWG, but their effectiveness has not been demonstrated. The purpose of this study was to evaluate, in a real-world setting, the effectiveness of a self-directed, integrated online and mobile phone behavioral intervention in preventing excessive GWG.MethodsThis effectiveness trial was a double-blind, three-arm trial with a parallel group design. Two arms received the same e-health intervention during pregnancy with the third arm serving as the placebo control. The intervention was based on a previously efficacious non-digital intervention that was adapted to electronic format. It included three behavior change tools: a weight gain tracker, and separate diet and physical activity goal-setting and self-monitoring tools. Both treatment conditions received access to informational tools, event reminders, and a blogging feature. Healthy pregnant women age 18-35 years with body mass indexes (BMI) ≥18.5 and < 35, at ≤20 weeks gestation, and an e-mail address were eligible. The proportion of women with excessive total GWG, as defined by the Institute of Medicine (IOM), was the primary outcome. 1689 randomized women were analyzed in the intent-to-treat (ITT) analysis. The study was designed to have 87% power to detect a 10 percentage point reduction from a control rate of 55% with a sample of 1641 (p = 0.0167, two-sided).ResultsIn the ITT sample, 48.1% (SD = 2.0%) gained excessively in the intervention group as did 46.2% (SD = 2.4%) in the placebo control group. These proportions were not significantly different (RR 1.09; 95% CI 0.98, 1.20, p = 0.12). The results were not altered in several sensitivity analyses.ConclusionThe addition of three behavior change tools to an informational placebo control did not result in a difference in the proportion of women with excessive total GWG compared to the placebo control in this effectiveness trial of an online, self-directed intervention. The similarity of intervention and control treatments and low usage of the behavior change tools in the intervention group are possible explanations.Trial registrationNCT01331564 , ClinicalTrials.gov.

Project description:ImportancePersonalized interventions that leverage workplace data and environments could improve effectiveness, sustainability, and scalability of employee wellness programs.ObjectiveTo test an automated behavioral intervention to prevent weight gain and improve diet using employee cafeteria purchasing data.Design, setting, and participantsThis individual-level randomized clinical trial of a 12-month intervention with 12 months of follow-up was conducted among employees of a hospital in Boston, Massachusetts, who purchased food at on-site cafeterias that used traffic-light labels (ie, green indicates healthy; yellow, less healthy; red, unhealthy). Participants were enrolled September 2016 to February 2018. Data were analyzed from May to September 2020.InterventionsFor 12 months, participants in the intervention group received 2 emails per week with feedback on previous cafeteria purchases and personalized health and lifestyle tips and 1 letter per month with peer comparisons and financial incentives for healthier purchases. Emails and letters were automatically generated using survey, health, and cafeteria data. Control group participants received 1 letter per month with general healthy lifestyle information.Main outcomes and measuresThe main outcome was change in weight from baseline to 12 months and 24 months of follow-up. Secondary outcomes included changes in cafeteria purchases, including proportion of green- and red-labeled purchases and calories purchased per day, from baseline (12 months preintervention) to the intervention (months 1-12) and follow-up (months 13-24) periods. Baseline Healthy Eating Index-15 (HEI-15) scores were compared to HEI-15 scores at 6, 12, and 24 months.ResultsAmong 602 employees enrolled (mean [SD] age, 43.6 [12.2] years; 478 [79.4%] women), 299 were randomized to the intervention group and 303 were randomized to the control group. Baseline mean (SD) body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) was 28.3 (6.6) and HEI-15 score was 60.4 (12.4). There were no between-group differences in weight change at 12 (0.2 [95% CI, -0.6 to 1.0] kg) or 24 (0.6 [95% CI, -0.3 to 1.4] kg) months. Compared with baseline, the intervention group increased green-labeled purchases by 7.3% (95% CI, 5.4% to 9.3%) and decreased red-labeled purchases by 3.9% (95% CI, -5.0% to -2.7%) and calories purchased per day by 49.5 (95% CI, -75.2 to -23.9) kcal more than the control group during the intervention period. In the intervention group, differences in changes in green (4.8% [95% CI, 2.9% to 6.8%]) and red purchases (-3.1% [95% CI, -4.3% to -2.0%]) were sustained at the 24-month follow-up. Differences in changes in HEI-15 scores were not significantly different in the intervention compared with the control group at 6 (2.2 [95% CI, 0 to 4.4]), 12 (1.8 [95% CI, -0.6 to 4.1]), and 24 (1.6, 95% CI, -0.7 to 3.8]) months.Conclusions and relevanceThe findings of this randomized clinical trial suggest that an automated behavioral intervention using workplace cafeteria data improved employees' food choices but did not prevent weight gain over 2 years.Trial registrationClinicalTrials.gov Identifier: NCT02660086.

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Randomized trial of a behavioral intervention to prevent excessive gestational weight gain: the Fit for Delivery Study.

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Randomized trial of a behavioral intervention to prevent excessive gestational weight gain: the Fit for Delivery Study.

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