Excessive 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. This 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). In 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. The 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. NCT01331564 , ClinicalTrials.gov.

Cardiovascular disease is the leading cause of death in the United States and places substantial burden on the health care system. Rural populations, especially women, have considerably higher rates of cardiovascular disease, influenced by poverty, environmental factors, access to health care, and social and cultural attitudes and norms. This community-based study will be a two-arm randomized controlled efficacy trial comparing a multi-level, community program (Strong Hearts, Healthy Communities) with a minimal intervention control program (Strong Hearts, Healthy Women). Strong Hearts, Healthy Communities was developed by integrating content from three evidence-based programs and was informed by extensive formative research (e.g. community assessments, focus groups, and key informant interviews). Classes will meet twice weekly for one hour for 24 weeks and focus on individual-level skill building and behavior change; social and civic engagement are also core programmatic elements. Strong Hearts, Healthy Women will meet monthly for hour-long sessions over the 24 weeks covering similar content in a general, condensed format. Overweight, sedentary women 40 years of age and older from rural, medically underserved communities (12 in Montana and 4 in New York) will be recruited; sites, pair-matched based on rurality, will be randomized to full or minimal intervention. Data will be collected at baseline, midpoint, intervention completion, and six-month, one-year, and eighteen months post-intervention. The primary outcome is change in body weight; secondary outcomes include physiologic, anthropometric, behavioral, and psychosocial variables. In the full intervention, engagement of participants’ friends and family members in partnered activities and community events is an intervention target, hypothesizing that there will be a reciprocal influence of physical activity and diet behavior between participants and their social network. Family members and/or friends will be invited to complete baseline and follow-up questionnaires about their health behaviors and environment, height and weight, and attitudes and beliefs. Strong Hearts, Healthy Communities aims to reduce cardiovascular disease morbidity and mortality, improve quality of life, and reduce cardiovascular disease-related health care burden in underserved rural communities. If successful, the long-term goal is for the program to be nationally disseminated, providing a feasible model to reduce cardiovascular disease in rural settings. ClinicalTrials.gov Identifier: NCT02499731 Registered on July 1, 2015.

Objective: The aim of this study was to evaluate a multilevel cardiovascular disease (CVD) prevention program for rural women.Methods: This 6‐month, community‐based, randomized trial enrolled 194 sedentary rural women aged 40 or older with BMI ≥ 25 kg/m². Intervention participants attended 6 months of twice‐weekly exercise, nutrition, and heart health classes (48 total) that included individual‐, social‐, and environment‐level components. An education‐only control program included didactic healthy lifestyle classes once a month (six total). The primary outcome measures were change in BMI and weight.Results: Within‐group and between‐group multivariate analyses revealed that only intervention participants decreased BMI (−0.85 units; 95% CI: −1.32 to −0.39; P = 0.001) and weight (−2.24 kg; 95% CI: −3.49 to −0.99; P = 0.002). Compared with controls, intervention participants decreased BMI (difference: −0.71 units; 95% CI: −1.35 to −0.08; P = 0.03) and weight (1.85 kg; 95% CI: −3.55 to −0.16; P = 0.03) and improved C‐reactive protein (difference: −1.15 mg/L; 95% CI: −2.16 to −0.15; P = 0.03) and Simple 7, a composite CVD risk score (difference: 0.67; 95% CI: 0.14 to 1.21; P = 0.01). Cholesterol decreased among controls but increased in the intervention group (−7.85 vs. 3.92 mg/dL; difference: 11.77; 95% CI: 0.57 to 22.96; P = 0.04).Conclusions: The multilevel intervention demonstrated modest but superior and meaningful improvements in BMI and other CVD risk factors compared with the control program.