Association of a Lifestyle Intervention with Blood Pressure Trajectories During Pregnancy and Postpartum in Women with Pre-pregnancy Overweight and Obesity.

OBJECTIVES: Healthy lifestyle, including healthy diet and physical activity, has been associated with lower blood pressure (BP). We hypothesized that overweight/obese women randomized to a lifestyle intervention beginning in early pregnancy would be less likely to have a higher BP trajectory. METHODS: The Health in Pregnancy and Postpartum study promoted a healthy lifestyle in pregnant and postpartum women with pre-pregnancy overweight or obesity. BP was measured at study visits at ≤ 16 and 32 weeks of pregnancy and 6 and 12 months postpartum. Latent class trajectories were constructed to identify groups of participants with similar BP patterns throughout the study period. Odds of being assigned to the higher BP trajectories between the intervention and control group were determined with logistic regression, adjusted for age, race, pre-pregnancy BMI, gestational weight gain, smoking during the study period, and household income. RESULTS: Of the 219 participants enrolled (44.3% Black participants, 55.7% White participants, mean age = 29.7 ± 0.3 years), 112 (51.1%) were randomized to the intervention. Two systolic and diastolic BP trajectory groups were identified (Low-Stable, Moderate-Increasing). Randomization to the lifestyle intervention was not associated with odds of Moderate-Increasing systolic (OR 0.83, 95%CI 0.4, 1.6) or diastolic (OR 0.67, 95%CI 0.3, 1.3) BP trajectory assignment. Those in the Moderate-Increasing BP groups had higher BMI and were more likely to have an adverse pregnancy outcome. CONCLUSIONS: A lifestyle intervention initiated in early pregnancy to help prevent excessive gestational weight gain was not associated with odds of specific BP patterns through pregnancy and postpartum.

Effects of a behavioral intervention on physical activity, diet, and health-related quality of life in pregnant women with elevated weight: results of the HIPP randomized controlled trial.

BACKGROUND: Physical activity (PA), diet, and health-related quality of life (HRQOL) are related to maternal and infant health, but interventions to improve these outcomes are needed in diverse pregnant women with elevated weight. METHODS: Health In Pregnancy and Postpartum (HIPP) was a randomized controlled trial. Women who were pregnant (N=219, 44% African American, 56% white) with overweight or obesity but otherwise healthy were randomized to a behavioral intervention grounded in Social Cognitive Theory (n=112) or to standard care (n=107). The intervention group received an in-depth counseling session, a private Facebook group, and 10 content-based counseling calls with accompanying behavioral podcasts followed by weekly or biweekly counseling calls until delivery. The standard care group received monthly mailings and 10 podcasts focused on healthy pregnancy. PA (SenseWear armband), diet (ASA24), and HRQOL (SF-12) measures were obtained from blinded assessors at baseline (<16 weeks) and late pregnancy (32 weeks). Mixed model repeated measures regression models tested treatment (Group x Time) and within-group effects. We hypothesized that intervention participants would have higher levels of PA, a better-quality diet, and higher HRQOL than standard care participants. Exploratory analyses examined whether changes in outcomes over time differed according to whether participants had recommended, excessive, or inadequate weight gain. RESULTS: Treatment effects favored intervention participants for vegetable intake (d=0.40, p<0.05) and % whole grains (d=0.60, p<0.01). HRQOL mental component improved in both groups, but less in intervention than standard care participants (d=-0.33, p<0.05). Time effects demonstrated that total PA, steps/day, and HRQOL physical component declined significantly in both groups. Within-group effects showed that diet quality significantly improved in intervention participants. Moderate-intensity PA declined significantly in standard care participants, whereas light-intensity PA declined and sedentary behavior increased significantly in intervention participants. Finally, exploratory analyses showed that total PA and light PA increased whereas sedentary behavior decreased among those meeting guidelines for weight gain, with opposite patterns seen among those with excessive or inadequate weight gain. CONCLUSIONS: The intervention improved several dietary outcomes but had modest impacts on PA and HRQOL, underscoring the challenge of behavior change during pregnancy. TRIAL REGISTRATION: This trial was registered in ClinicalTrials.gov on 10/09/2014. NCT02260518.

Process evaluation methods and results from the Health in Pregnancy and Postpartum (HIPP) randomized controlled trial.

BACKGROUND: Excessive gestational weight gain has increased over time and is resistant to intervention, especially in women living with overweight or obesity. This study described the process evaluation methods and findings from a behavioral lifestyle intervention for African American and white women living with overweight and obesity that spanned pregnancy (≤ 16 weeks gestation) through 6 months postpartum. METHODS: The Health in Pregnancy and Postpartum (HIPP) study tested a theory-based behavioral intervention (vs. standard care) to help women (N = 219; 44% African American, 29.1 ± 4.8 years) living with overweight or obesity meet weight gain guidelines in pregnancy and lose weight in postpartum. Participants completed process evaluation surveys at 32 weeks gestation (n = 183) and 6 months postpartum (n = 168) regarding their perceptions of most and least helpful aspects of the intervention. A database tracked delivery and receipt of intervention components (in-depth counseling session, telephone calls, podcasts). Descriptive statistics are used to report fidelity, dose, and participants' perceptions. We also tested whether dose of behavioral intervention components was associated with gestational weight gain and 6-month postpartum weight retention with linear regression models controlling for baseline age and gestational weeks, receipt of Medicaid, race, parity, and marital status. A content analysis was used to code and analyze responses to open-ended survey questions. RESULTS: Over 90% of participants (both groups) would recommend the program to a friend. Implementation fidelity was moderately high and greater in pregnancy than postpartum for all intervention components. Dose received and participants' ratings of the in-depth counseling session and telephone calls were more favorable than podcasts. The Facebook group was not perceived to be very helpful, likely because of low participant interaction. Although podcasts were created to reinforce call topics, this redundancy was viewed negatively by some. More calls completed and more podcasts downloaded related to lower gestational weight gain (p < .05). CONCLUSION: Study findings underscore challenges in engaging this important but busy population, especially during the postpartum period. TRIAL REGISTRATION: The study was registered at clinicaltrials.gov (NCT02260518) on 10/09/2014. https://clinicaltrials.gov/ct2/show/NCT02260518 .

Effects of a lifestyle intervention on postpartum weight retention among women with elevated weight.

OBJECTIVE: The effectiveness of a pregnancy and postpartum behavioral lifestyle intervention on postpartum weight retention was examined. METHODS: Pregnant women with overweight and obesity in South Carolina were recruited into a theory-based randomized controlled trial (n = 112 intervention, n = 107 standard care), which was designed to reduce gestational weight gain and postpartum weight retention. RESULTS: Participants (44% African American, 56% White) had a mean prepregnancy BMI of 32.3 kg/m2 and were at 12.6 weeks' gestation at baseline. From prepregnancy to 6 months post partum, intervention participants retained less weight than standard care women (mean difference: -3.6 kg, 95% CI: -5.5 to -1.8). The intervention effect was maintained at 12 months post partum (mean difference: -2.4 kg, 95% CI: -4.3 to -0.5). Intervention women had 2.3 times higher odds of having no weight retention at 6 months post partum versus standard care women (95% CI: 1.2 to 4.4). Intervention participants also had lower odds of retaining ≥5% of their prepregnancy weight after delivery (adjusted odds ratio: 0.3, 95% CI: 0.1 to 0.5 at 6 months; adjusted odds ratio: 0.3, 95% CI: 0.2 to 0.6 at 12 months). CONCLUSION: This theory-based lifestyle intervention resulted in significantly less weight retention at 6 and 12 months after delivery among pregnant women with overweight and obesity.

A Behavioral Lifestyle Intervention to Limit Gestational Weight Gain in Pregnant Women with Overweight and Obesity.

OBJECTIVE: This study aimed to evaluate the effects of an antenatal behavioral lifestyle intervention on total gestational weight gain (GWG) and perinatal outcomes. METHODS: Pregnant women with overweight and obesity in South Carolina were recruited into a theory-based randomized controlled trial (n = 112 intervention, n = 105 standard care), which was designed to target weight self-monitoring, increased physical activity, and improved dietary practices. RESULTS: Participants were racially/ethnically diverse (44% African American). Intervention and standard care participants had similar total GWG at delivery (12.9 ± 6.9 vs. 12.4 ± 8.3 kg, respectively), but intervention participants had a smaller standard deviation (P = 0.04) in total GWG. The treatment effects were moderated by race/ethnicity and prepregnancy BMI. Among African American participants with overweight, intervention participants gained 4.5 kg less, whereas, among African American women with obesity, intervention participants gained 4.1 kg more than standard care participants. Total GWG among White participants was similar regardless of weight status and group assignment. Fewer intervention participants than standard care participants had adverse pregnancy outcomes (P ≤ 0.01). CONCLUSIONS: The behavioral lifestyle intervention favorably impacted GWG in African American participants with overweight but not African American participants with obesity. The intervention's overall favorable impact on perinatal outcomes suggests that the mechanisms beyond total GWG may drive these outcomes.

Strategies and Challenges in Recruiting Pregnant Women with Elevated Body Mass Index for a Behavioral Lifestyle Intervention.

Purpose: Pregnant women with elevated body mass index (BMI) are difficult to recruit into lifestyle studies. This article (1) summarized strategies to recruit pregnant women into a randomized trial, and (2) reported recruitment statistics and their correlates. Materials and Methods: African American and white women with BMI ≥25 and gestational age <16 weeks were recruited primarily through obstetric clinics into the Health in Pregnancy and Postpartum study. Women completed a brief screening form, and if initially eligible, a phone screening. We compared characteristics of those randomized versus not randomized. Results: Initially eligible pregnant women (N = 1578) were identified through direct recruitment by research staff, indirect recruitment by clinic staff at obstetric clinics, and self-referrals through advertisements. Of these women, 54.0% (850) were reached for further screening, and 43.5% (685) were fully eligible. Among eligible women, 58.8% (403) were scheduled for a baseline visit, and 33.3% (228) were randomized. The overall recruitment yield was 14.4%. Recruited participants were diverse (44% African Americans) and averaged 12.6 weeks gestation at baseline. Randomized (vs. nonrandomized) women were more likely to own a cell phone, have access to a computer with internet at home or work, and have downloaded a podcast. Conclusions: Although this study did not reach the recruitment goal, a relatively large and diverse sample of pregnant women were recruited early in pregnancy. Recruiting women with elevated BMI for a behavioral lifestyle intervention is challenging, particularly among women with characteristics, including less phone and internet access and limited experience in using podcasts. This study is registered at Clinicaltrials.gov: NCT02260518.

A randomized controlled trial to prevent excessive gestational weight gain and promote postpartum weight loss in overweight and obese women: Health In Pregnancy and Postpartum (HIPP).

BACKGROUND: Interventions to prevent excessive gestational weight gain and promote postpartum weight loss have yielded modest results, particularly in overweight and obese women. OBJECTIVES: To examine the impact of a theory-based lifestyle intervention on gestational weight gain, postpartum weight loss, and related maternal and child outcomes and to examine race differences in these outcomes. DESIGN: A randomized controlled trial (target N=400; 200 intervention, 200 standard care; 200 African American, 200 white). METHODS: Overweight and obese African American and white women ≤16weeks gestation are recruited from obstetrics and gynecology clinics in South Carolina. Intervention participants receive two in-depth counseling sessions (early pregnancy and postpartum), telephone counseling, behavioral podcasts, and social media support that target weight self-monitoring and increasing physical activity and healthy dietary behavior practices, guided by Social Cognitive Theory. Standard care participants receive monthly mailings and a matched number of podcasts on non-weight related topics. All intervention activities last from ≤18weeks gestation to 6months after delivery. Gestational weight gain is the primary outcome. Secondary outcomes are meeting gestational weight gain guidelines (inadequate, adequate, excessive), weekly rate of gestational weight gain, postpartum weight retention, physical activity and dietary behaviors, health-related quality of life, and offspring adiposity. Participants are assessed at baseline (≤16weeks gestation), 32weeks gestation, and 6 and 12months postpartum, and offspring are assessed at 6 and 12months. SUMMARY: HIPP is an innovative study that addresses significant gaps in the literature. Primary outcome results are expected in 2019.

Comparative effectiveness of plant-based diets for weight loss: a randomized controlled trial of five different diets.

OBJECTIVE: The aim of this study was to determine the effect of plant-based diets on weight loss. METHODS: Participants were enrolled in a 6-mo, five-arm, randomized controlled trial in 2013 in South Carolina. Participants attended weekly group meetings, with the exception of the omnivorous group, which served as the control and attended monthly meetings augmented with weekly e-mail lessons. All groups attended monthly meetings for the last 4 mo of the study. Diets did not emphasize caloric restriction. RESULTS: Overweight adults (body mass index 25-49.9 kg/m(2); age 18-65 y, 19% non-white, and 27% men) were randomized to a low-fat, low-glycemic index diet: vegan (n = 12), vegetarian (n = 13), pesco-vegetarian (n = 13), semi-vegetarian (n = 13), or omnivorous (n = 12). Fifty (79%) participants completed the study. In intention-to-treat analysis, the linear trend for weight loss across the five groups was significant at both 2 (P < 0.01) and 6 mo (P < 0.01). At 6 mo, the weight loss in the vegan group (-7.5% ± 4.5%) was significantly different from the omnivorous (-3.1% ± 3.6%; P = 0.03), semi-vegetarian (-3.2% ± 3.8%; P = 0.03), and pesco-vegetarian (-3.2% ± 3.4%; P = 0.03) groups. Vegan participants decreased their fat and saturated fat more than the pesco-vegetarian, semi-vegetarian, and omnivorous groups at both 2 and 6 mo (P < 0.05). CONCLUSIONS: Vegan diets may result in greater weight loss than more modest recommendations.

Randomization to plant-based dietary approaches leads to larger short-term improvements in Dietary Inflammatory Index scores and macronutrient intake compared with diets that contain meat.

Studies have examined nutrient differences among people following different plant-based diets. However, all of these studies have been observational. The aim of the present study was to examine differences in nutrient intake and Dietary Inflammatory Index (DII) scores among overweight and obese (body mass index 25.0-49.9 kg/m(2)) adults randomized to receive dietary instruction on a vegan (n = 12), vegetarian (n = 13), pescovegetarian (n = 13), semivegetarian (n = 13), or omnivorous (n = 12) diet during a 6-month randomized controlled trial. Nutrient intake, nutrient adequacy, and DII score were assessed via two 24-hour dietary recalls (Automated Self-Administered 24-Hour Dietary Recall) at baseline and at 2 and 6 months. Differences in nutrient intake and the DII were examined using general linear models with follow-up tests at each time point. We hypothesized that individuals randomized to the vegan diet would have lower DII scores and greater improvements in fiber, carbohydrate, fat, saturated fat, and cholesterol at both 2 and 6 months as compared with the other 4 diets. Participants randomized to the vegan diet had significantly greater changes in most macronutrients at both time points, including fat and saturated fat, as well as cholesterol and, at 2 months, fiber, as compared with most of the other diet groups (Ps < .05). Vegan, vegetarian, and pescovegetarian participants all saw significant improvements in the DII score as compared with semivegetarian participants at 2 months (Ps < .05) with no differences at 6 months. Given the greater impact on macronutrients and the DII during the short term, finding ways to provide support for adoption and maintenance of plant-based dietary approaches, such as vegan and vegetarian diets, should be given consideration.

Low glycemic index vegan or low-calorie weight loss diets for women with polycystic ovary syndrome: a randomized controlled feasibility study.

The aim of this randomized pilot was to assess the feasibility of a dietary intervention among women with polycystic ovary syndrome (PCOS) comparing a vegan to a low-calorie (low-cal) diet. Overweight (body mass index, 39.9 ± 6.1 kg/m(2)) women with PCOS (n = 18; age, 27.8 ± 4.5 years; 39% black) who were experiencing infertility were recruited to participate in a 6-month randomized weight loss study delivered through nutrition counseling, e-mail, and Facebook. Body weight and dietary intake were assessed at 0, 3, and 6 months. We hypothesized that weight loss would be greater in the vegan group. Attrition was high at 3 (39%) and 6 months (67%). All analyses were conducted as intention-to-treat and presented as median (interquartile range). Vegan participants lost significantly more weight at 3 months (-1.8% [-5.0%, -0.9%] vegan, 0.0 [-1.2%, 0.3%] low-cal; P = .04), but there was no difference between groups at 6 months (P = .39). Use of Facebook groups was significantly related to percent weight loss at 3 (P < .001) and 6 months (P = .05). Vegan participants had a greater decrease in energy (-265 [-439, 0] kcal/d) and fat intake (-7.4% [-9.2%, 0] energy) at 6 months compared with low-cal participants (0 [0, 112] kcal/d, P = .02; 0 [0, 3.0%] energy, P = .02). These preliminary results suggest that engagement with social media and adoption of a vegan diet may be effective for promoting short-term weight loss among women with PCOS; however, a larger trial that addresses potential high attrition rates is needed to confirm these results.

Age-dependent recall bias for material of internal versus external origin.

OBJECTIVE: To learn whether young and aged subjects exhibit different recall biases for internally derived (Internal) versus externally supplied (External) material. BACKGROUND: Internally derived knowledge, prized by educators and therapists, can bring about dramatic behavioral change. Such information, seldom assessed on formal memory testing, may be preferentially recalled compared with external-origin material. Under some circumstances, however, subjects may demonstrate a recall advantage for externally supplied over internally generated material. METHOD: We compared Internal and External word recall in young and aged subjects with and without explicit intent to remember. RESULTS: Although overall the young and aged subjects recalled the same number of words, we did find a word-origin recall bias. This recall bias differed by age group (P = 0.005). When not instructed to remember words, the young subjects tended to remember more External words, while aged subjects remembered more Internal words. CONCLUSIONS: The differences in the brain mechanisms mediating Internal versus External recall bias are unknown. However, aging may modify an Internal-External memory bias.

Brachioradial pruritus: cervical spine disease and neurogenic/neuropathic [corrected] pruritus.

BACKGROUND: The main cause of brachioradial pruritus (BRP) is not known but there is evidence to suggest that BRP may arise in the nervous system. Cervical spine disease may be an important contributing factor. OBJECTIVE: Our aim was to determine whether spine pathology is associated with BRP. METHODS: Medical charts of patients with BRP seen in the Division of Dermatology of the University of Massachusetts Medical Center between the years of 1993 and 2000 were retrospectively analyzed. On the basis of clinical index of suspicion, some patients had undergone radiography of the spine. RESULTS: Of 22 patients with BRP, 11 had cervical spine radiographs. The radiographs showed cervical nnspine disease that could be correlated with the location of pruritus in each of these 11 patients. CONCLUSIONS: Patients with BRP may have underlying cervical spine pathology. Whether this association is causal or coincidental remains to be determined.