Family-based obesity prevention for infants: Design of the “Mothers & Others” randomized trial

Objective Our goal is to test the efficacy of a family-based, multi-component intervention focused on infants of African-American (AA) mothers and families, a minority population at elevated risk for pediatric obesity, versus a child safety attention-control group to promote healthy weight gain patterns during the first two years of life. Design, participants, and methods The design is a two-group randomized controlled trial among 468 AA pregnant women in central North Carolina. Mothers and study partners in the intervention group receive anticipatory guidance on breastfeeding, responsive feeding, use of non-food soothing techniques for infant crying, appropriate timing and quality of complementary feeding, age-appropriate infant sleep, and minimization of TV/media. The primary delivery channel is 6 home visits by a peer educator, 4 interim newsletters and twice-weekly text messaging. Intervention families also receive 2 home visits from an International Board Certified Lactation Consultant. Assessments occur at 28 and 37 weeks gestation and when infants are 1, 3, 6, 9, 12, and 15 months of age. Results The primary outcome is infant/toddler growth and likelihood of overweight at 15 months. Differences between groups are expected to be achieved through uptake of the targeted infant feeding and care behaviors (secondary outcomes) and change in caregivers' modifiable risk factors (mediators) underpinning the intervention. Conclusions If successful in promoting healthy infant growth and enhancing caregiver behaviors, “Mothers and Others” will have high public health relevance for future obesity-prevention efforts aimed at children younger than 2 years, including interventional research and federal, state, and community health programs. Trial Registration ClinicalTrials.gov, NCT01938118, August 9, 2013

Consumption of key food groups during the postpartum period in low-income, non-Hispanic black mothers

The postpartum period can impact diet quality and subsequently place women at greater risk for overweight or obesity. This study examined consumption of key food groups during the first 2 years postpartum among low income, non-Hispanic black, first-time mothers. Data were from the Infant Care, Feeding and Risk of Obesity Study, a cohort of 217 mother–infant dyads, followed from 3 to 18 months postpartum, collected from 2003 to 2007. At each study visit (3, 6, 9, 12, and 18 months) 24-h dietary recalls were collected. Consumption levels were compared to those recommended from the 2010 Dietary Guidelines for Americans (DGAs) for each of the following food groups: fruits, vegetables, grains, whole grains, protein foods and dairy, as well as an estimated upper limit for sugar-sweetened beverage (SSB) consumption. At each time point, mothers met recommended intake levels for grains and protein foods only. In random-intercept logistic regression models, no demographic or household characteristics were associated with a likelihood of consuming recommended levels for any of the food groups according to the DGAs. Given the low intake of fruits, vegetables, whole grains and lean protein foods and high intake of SSBs and refined grains, interventions targeting women's diet during the postpartum period are warranted

Consumption of obesogenic foods in non-Hispanic black mother–infant dyads

Obesity continues to be a problem in the United States. Of particular concern is the epidemic of early childhood obesity. A significant predictor of child diet is maternal diet, but little is known about this relationship during infancy. This study examined the association between maternal and infant consumption of key food groups from 6 to 18 months using data from the Infant Care, Feeding, and Risk of Obesity Study, a prospective cohort of 217 non-Hispanic black, low-income, first-time mothers. Using data from 24-hr dietary recalls collected during in-home visits at 6, 9, 12, and 18 months, we assessed longitudinal associations between mother and child intake of both energy-dense, nutrient-poor (obesogenic) food groups and fibre-, nutrient-rich food groups using random intercept logistic regression. Both mothers and their infants had high intake of sugar-sweetened beverages, desserts, and sweets and low intake of vegetables and whole grains. Infant consumption of key food groups was strongly associated with maternal consumption, suggesting the need for focused interventions to target maternal diet as a pathway to decreasing risk for the establishment of poor dietary patterns early in life

A sixteen-week three-armed, randomized, controlled trial investigating clinical and biochemical effects of targeted alterations in dietary linoleic acid and n-3 EPA+DHA in adults with episodic migraine: Study protocol

Migraine is a prevalent neurological disorder, affecting over 16% of adult women and 7% of adult men in the U.S., causing significant pain, disability, and medical expense, with incomplete benefits from conventional medical management. Migraine, as a chronic pain syndrome, provides a practical model for investigating the impact of dietary modifications in omega-3 (n-3) and omega-6 (n-6) fatty acids. This paper reports the protocol of a trial to assess whether targeted dietary modifications designed to increase n-3 eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), with or without concurrent reduction in n-6 linoleic acid (LA), will alter nociceptive lipid mediators and mediate decreases in frequency and severity of migraine. This prospective, randomized, controlled trial in 153 male and female adult subjects, ages 18–99, with diagnosed and actively managed episodic migraine tests the efficacy, safety, and biochemical effects of targeted, controlled alterations in dietary omega-3 and omega-6 fatty acids. Participants are masked to diet hypotheses and all assessors are masked to treatment assignment. Following a four-week baseline period, participants with migraine headache frequency of 5–20 per month are randomized to one of three intensive dietary regimens for 16 additional weeks followed by a less intensive observation period. Dietary intervention arms include: 1) increased n-3 EPA+DHA with low n-6 linoleic acid (H3 L6); 2) increased n-3 EPA+DHA with usual US dietary intake of n-6 linoleic acid (H3 H6); and 3) usual US dietary content of n-3 and n-6 fatty acids (L3 H6). During the actual intervention, subjects receive content-specific study oils and foods sufficient for two meals and two snacks per day, as well as dietary counseling. Biochemical and clinical outcome measures are performed at intervals throughout this period. This randomized controlled trial is designed to determine whether targeted alterations in dietary n-3 and n-6 fatty acids can alter nociceptive lipid mediators in a manner that decreases headache pain and enhances quality of life and function in adults with frequent migraines. Trial registration NCT0201279

Community mobilization to modify harmful gender norms and reduce HIV risk: results from a community cluster randomized trial in South Africa

Introduction: Community mobilization (CM) is increasingly recognized as critical to generating changes in social norms and behaviours needed to achieve reductions in HIV. We conducted a CM intervention to modify negative gender norms, particularly among men, in order to reduce associated HIV risk. Methods: Twenty two villages in the Agincourt Health and Socio-Demographic Surveillance Site in rural Mpumalanga, South Africa were randomized to either a theory-based, gender transformative, CM intervention or no intervention. Two cross-sectional, population-based surveys were conducted in 2012 (pre-intervention, n = 600 women; n = 581 men) and 2014 (post-intervention, n = 600 women; n = 575 men) among adults ages 18 to 35 years. We used an intent-to-treat (ITT) approach using survey regression cluster-adjusted standard errors to determine the intervention effect by trial arm on gender norms, measured using the Gender Equitable Mens Scale (GEMS), and secondary behavioural outcomes. Results: Among men, there was a significant 2.7 point increase (Beta Coefficient 95% CI: 0.62, 4.78, p = 0.01) in GEMS between those in intervention compared to control communities. We did not observe a significant difference in GEMS scores for women by trial arm. Among men and women in intervention communities, we did not observe significant differences in perpetration of intimate partner violence (IPV), condom use at last sex or hazardous drinking compared to control communities. The number of sex partners in the past 12 months (AOR 0.29, 95% CI 0.11 to 0.77) were significantly lower in women in intervention communities compared to control communities and IPV victimization was lower among women in intervention communities, but the reduction was not statistically significant (AOR 0.53, 95% CI 0.24 to 1.16). Conclusion: Community mobilization can reduce negative gender norms among men and has the potential to create environments that are more supportive of preventing IPV and reducing HIV risk behaviour. Nevertheless, we did not observe that changes in attitudes towards gender norms resulted in desired changes in risk behaviours suggesting that more time may be necessary to change behaviour or that the intervention may need to address behaviours more directly. Clinical Trials number: ClinicalTrials.gov NCT02129530

Estimation of Fecundity and Secondary Sterility from Survey Data on Birth Intervals in Egypt

Data on the last closed and open birth intervals have been used to ascertain the current potential of childbearing for women in terms of estimating fecundity and secondary sterility by age, residence, and educational subgroup. Under the assumption that after a specific period from the last birth a certain proportion of women become secondarily sterile, we propose and apply an inflated model of open birth interval to obtain the proportion of women who are secondarily sterile. The data used for the analysis are extracted from the Egyptian Fertility Survey conducted in 1980