A Home Visiting Parenting Program and Child Obesity: A Randomized Trial

BACKGROUND Young children living in historically marginalized families are at risk for becoming adolescents with obesity and subsequently adults with increased obesity-related morbidities. These risks are particularly acute for Hispanic children. We hypothesized that the prevention-focused, socioecological approach of the “Minding the Baby” (MTB) home visiting program might decrease the rate of childhood overweight and obesity early in life. METHODS This study is a prospective longitudinal cohort study in which we include data collected during 2 phases of the MTB randomized controlled trial. First-time, young mothers who lived in medically underserved communities were invited to participate in the MTB program. Data were collected on demographics, maternal mental health, and anthropometrics of 158 children from birth to 2 years. RESULTS More children in the intervention group had a healthy BMI at 2 years. The rate of obesity was significantly higher (P < .01) in the control group (19.7%) compared with the intervention group (3.3%) at this age. Among Hispanic families, children in the MTB intervention were less likely to have overweight or obesity (odds ratio = 0.32; 95% confidence interval: 0.13–0.78). CONCLUSIONS Using the MTB program, we significantly lowered the rate of obesity among 2-year-old children living in low-socioeconomic-status communities. In addition, children of Hispanic mothers were less likely to have overweight or obesity at 2 years. Given the high and disproportionate national prevalence of Hispanic young children with overweight and obesity and the increased costs of obesity-related morbidities, these findings have important clinical, research, and policy implications.

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Weight Reduction by the Low-Insulin-Method—A Randomized Controlled Trial

Nutrients ◽

10.3390/nu12103004 ◽

2020 ◽

Vol 12 (10) ◽

pp. 3004

Author(s):

Martin Röhling ◽

Katharina Martin ◽

Sabine Ellinger ◽

Michael Schreiber ◽

Stephan Martin ◽

...

Keyword(s):

Weight Reduction ◽

Controlled Trial ◽

Fasting Blood Glucose ◽

Group Analysis ◽

Intervention Group ◽

Eating Behaviour ◽

Control Group ◽

Insulin Levels ◽

Overweight Or Obesity

Continuous high insulin levels are associated with weight gain and lead to cardiometabolic diseases. Therefore, we have developed the Low-Insulin-Method and integrated it into the multi-component, occupational healthcare program SHAPE-AND-MOTION-Medical-Accompanied-Slimming (SAMMAS) to reduce daily insulin levels for long-term weight reduction in overweight or obesity. Employees were randomized into a starting intervention group (SI, n = 15) or waiting list control group (WL, n = 15). SAMMAS consisted of group-based seminars, low-carbohydrate nutrition including formula diet, continuous glucose monitoring, telemetric monitoring, and telemedical coaching. Both groups received telemetric devices at baseline. Intention-to-treat analyses were performed after 12, 26, and 52 weeks. The estimated treatment difference in weight reduction after 12 weeks, which is the primary endpoint of the study, showed a pronounced effect in favour of SI (−6.3 kg with (95% confidence interval) (−7.4; −4.5) (p < 0.001)) after 12 weeks. Furthermore, SI improved fasting blood glucose, HbA1c, quality of life, fasting insulin, blood pressure, and eating behaviour (all p < 0.05) in the within-group analysis, while WL did not. After 26 and 52 weeks, weight reduction could be maintained in the whole group (both groups together) by −6.7 kg (−9.5; −3.8) (p < 0.001) and −6.1 kg (−9.2; −2.7) (p < 0.01). SAMMAS supports clinically relevant weight reduction and long-term weight loss maintenance in individuals with overweight or obesity.

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The Effect of Providing Eggs Early in Complementary Feeding on Energy Intake and Dietary Diversity: The Mazira Project Randomized Controlled Trial

Current Developments in Nutrition ◽

10.1093/cdn/nzaa053_068 ◽

2020 ◽

Vol 4 (Supplement_2) ◽

pp. 863-863

Author(s):

Chessa Lutter ◽

Bess Caswell ◽

Charles Arnold ◽

Lora Iannotti ◽

Elizabeth Prado ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Young Children ◽

Energy Intake ◽

Complementary Feeding ◽

Dietary Diversity ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Minimum Dietary Diversity

Abstract Objectives Complementary feeding diets in low- and middle-income countries are usually inadequate to meet requirements for healthy growth and development. Food-based interventions may prevent nutrient inadequacies provided they do not replace other nutrient-rich foods. They may also be more sustainable than manufactured food supplements. We describe the contribution of daily egg supplementation to usual energy intake, usual energy intake by food group, and minimum dietary diversity of rural Malawian infants and young children. Methods We conducted a randomized controlled trial in rural Malawi in which 660 children aged 6 to 9 months were randomly allocated to receive an egg a day for 6 months or to a control group. Dietary intake of foods and drinks was assessed at baseline, 3-month midline, and 6-month endline visits using a tablet-based mulitpass 24-hour recall. Up to two repeat recalls were collected at each timepoint in a subsample of 100 children per intervention group. Results The intervention resulted in an increased usual energy intake in the intervention group of 30 kcal at midline (P = 0.128) and 36 kcal at endline (P = 0.087). It also resulted in a 7 kcal displacement of legumes and nuts in children at endline (P = 0.059). At midline and endline, usual energy intake from eggs was about 30 kcal higher in the egg group compared to controls (P < 0.0001). Compared to controls, children in the egg group were over 9 times more likely to consume eggs at midline and endline. At midline and endline more than 80% of children in the egg group consumed a minimally diverse diet compared to 53% at midline and 60% at endline in the control group. Conclusions Mothers in the egg group fed eggs to young children on a regular basis without substantial displacement of other nutrient-rich complementary foods. The intervention resulted in higher energy intake from eggs, greater dietary diversity, and an increased percentage of children meeting a minimum dietary diversity cutoff. Funding Sources Bill & Melinda Gates Foundation.

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The effectiveness of the Volunteer Family Connect Program in supporting vulnerable families: A randomised controlled trial intention-to-treat analysis of primary outcome variables (Preprint)

10.2196/preprints.13023 ◽

2018 ◽

Author(s):

Rebekah Grace ◽

Kelly Baird ◽

Emma Elcombe ◽

Vana Webster ◽

Jacqueline Barnes ◽

...

Keyword(s):

Young Children ◽

Home Visiting ◽

Controlled Trial ◽

Intervention Group ◽

Parenting Competence ◽

Community Connectedness ◽

Intention To Treat ◽

Vulnerable Families ◽

Secondary Outcomes ◽

Treat Analysis

BACKGROUND Volunteer home visiting is a widely adopted community-based approach to supporting families by linking isolated or vulnerable families with community volunteers. This study seeks to robustly evaluate the effectiveness of this model of support for families with young children. OBJECTIVE This paper reports the intention-to-treat analysis of primary and secondary outcomes for a pragmatic randomized controlled trial (RCT) of the Volunteer Family Connect intervention, a volunteer home visiting program designed to support families with young children who experience social isolation or a lack of parenting confidence and skills. METHODS The RCT was conducted across seven sites in Australia. Overall, 341 families were recruited: 169 intervention (services as usual + volunteer home visiting) and 172 control (services as usual) families. Intervention families received the program for 3-12 months. Participants were invited to complete six data collection points over a 15-month period. Primary outcomes were community connectedness and parenting competence. Secondary outcomes included parent physical and mental health, general parent wellbeing, parent empowerment, the sustainability of family routines, and the parent-child relationship. RESULTS The intervention group demonstrated significant improvement compared to the control group in both of the primary outcomes. They were significantly more like to report improvements in the guidance available to them as measured by the Social Provisions Scale, a key measure of community connectedness and scores on the Parenting Sense of Competence Scale were significantly in favour of the intervention group. Intervention families also reported significantly higher wellbeing, and were significantly more likely to feel that life was improving. A number of positive trends were also evident within the findings. CONCLUSIONS The Volunteer Family Connect intervention was considered to be an effective intervention for improving the community connectedness and parenting competence of families with young children. CLINICALTRIAL Australian New Zealand Clinical Trial Registry (Trial ID: ACTRN12616000396426).

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Effect of a Multicomponent mHealth Intervention on the Composition of Diet in a Population with Overweight and Obesity—Randomized Clinical Trial EVIDENT 3

Nutrients ◽

10.3390/nu14020270 ◽

2022 ◽

Vol 14 (2) ◽

pp. 270

Author(s):

Cristina Lugones-Sánchez ◽

José I. Recio-Rodríguez ◽

Marta Menéndez-Suárez ◽

Alicia Saz-Lara ◽

José I. Ramirez-Manent ◽

...

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Overweight And Obesity ◽

Control Group ◽

Food Groups ◽

Support Tool ◽

Mhealth Intervention ◽

Activity Tracker ◽

Balanced Diet ◽

Brief Advice

A balanced diet can help in the prevention of chronic diseases. The aim of this study was to evaluate the effect of an mHealth intervention on the distribution of macronutrients and the intake of food groups. A total of 650 participants were included in this multi-center, clinical, randomized, controlled trial (Evident 3 study). All participants were given brief advice about diet and exercise. The intervention group received, in addition, an app (Evident 3) for the self-recording of their diet and an activity tracker wristband for 3 months. Follow-up visits were performed at 3 and 12 months to collect the diet composition using the Food Frequency Questionnaire. There were decreases in the intake of total calories, fat, protein and carbohydrates in both groups throughout the study, without significant differences between them. The intervention group reduced the intake of cholesterol (−30.8; 95% CI −59.9, −1.7) and full-fat dairies (−23.3; 95% CI −42.8, −3.8) and increased the intake of wholemeal bread (3.3; 95% CI −6.7, 13.3) and whole-grain cereals (3.4; 95% CI −6.8, 13.7) with respect to the control group. No differences were found in the rest of the nutritional parameters. The brief advice is useful to promote a healthier diet, and the app can be a support tool to obtain changes in relevant foods, such as integral foods, and the intake of cholesterol. Trial registration: ClinicalTrials.gov with identifier NCT03175614.

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A parent-directed language intervention for children of low socioeconomic status: a randomized controlled pilot study

Journal of Child Language ◽

10.1017/s0305000915000033 ◽

2015 ◽

Vol 43 (2) ◽

pp. 366-406 ◽

Cited By ~ 84

Author(s):

DANA L. SUSKIND ◽

KRISTIN R. LEFFEL ◽

EILEEN GRAF ◽

MARC W. HERNANDEZ ◽

ELIZABETH A. GUNDERSON ◽

...

Keyword(s):

Socioeconomic Status ◽

Language Development ◽

Low Socioeconomic Status ◽

Home Visiting ◽

Child Language ◽

Controlled Trial ◽

Control Group ◽

Post Intervention ◽

Randomized Controlled ◽

Home Based

AbstractWe designed a parent-directed home-visiting intervention targeting socioeconomic status (SES) disparities in children's early language environments. A randomized controlled trial was used to evaluate whether the intervention improved parents' knowledge of child language development and increased the amount and diversity of parent talk. Twenty-three mother–child dyads (12 experimental, 11 control, aged 1;5–3;0) participated in eight weekly hour-long home-visits. In the experimental group, but not the control group, parent knowledge of language development increased significantly one week and four months after the intervention. In lab-based observations, parent word types and tokens and child word types increased significantly one week, but not four months, post-intervention. In home-based observations, adult word tokens, conversational turn counts, and child vocalization counts increased significantly during the intervention, but not post-intervention. The results demonstrate the malleability of child-directed language behaviors and knowledge of child language development among low-SES parents.

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Early Nutritional Education in the Prevention of Childhood Obesity

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18126569 ◽

2021 ◽

Vol 18 (12) ◽

pp. 6569

Author(s):

Mario Gato-Moreno ◽

María F. Martos-Lirio ◽

Isabel Leiva-Gea ◽

M. Rosa Bernal-López ◽

Fernando Vegas-Toro ◽

...

Keyword(s):

Educational Intervention ◽

Intervention Group ◽

Overweight And Obesity ◽

The Body ◽

Secondary Outcome ◽

Outcome Variable ◽

Controlled Study ◽

Control Group ◽

Nutritional Education ◽

Overweight Or Obesity

Early childhood is a critical period for obesity prevention. This randomized controlled study evaluated the effectiveness of an educational intervention preventing obesity in preschool-age children. A nutritional education intervention, with a follow-up session one year later, was conducted with parents of children aged 3 to 4 years of public schools in the province of Málaga. The main outcome variable was the body mass index z-score (zBMI). The prevalence of overweight or obesity was the secondary outcome variable. The sample comprised 261 students (control group = 139). Initial BMI, weight, height-for-age and prevalence of overweight and obesity were similar for both groups. After the first year of the intervention, the zBMI of the intervention group decreased significantly from 0.23 to 0.10 (p = 0.002), and the subgroup of patients with baseline zBMI above the median decreased from 1 to 0.72 (p = 0.001), and in the second year from 1.01 to 0.73 (p = 0.002). The joint prevalence of overweight and obesity increased in the control group (12.2% to 20.1%; p = 0.027), while in the intervention group, there were no significant changes. This preschool educational intervention with parents improved their children’s BMI, especially those with a higher BMI for their age, and favored the prevention of overweight or obesity.

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Effects of a 12-week Avocado Randomized-controlled Trial on Cognitive Function and Lutein Status Among Adults with Overweight and Obesity (OR05-01-19)

Current Developments in Nutrition ◽

10.1093/cdn/nzz029.or05-01-19 ◽

2019 ◽

Vol 3 (Supplement_1) ◽

Author(s):

Caitlyn Edwards ◽

Anne Walk ◽

Sharon Thompson ◽

Ginger Reeser ◽

John Erdman ◽

...

Keyword(s):

Cognitive Function ◽

Selective Attention ◽

Flanker Task ◽

Controlled Trial ◽

Intervention Group ◽

Overweight And Obesity ◽

Controlled Study ◽

Control Group ◽

Daily Consumption ◽

Randomized Controlled

Abstract Objectives Overweight and obesity affect over two-thirds of the US population. This is concerning, as excess adiposity increases risk for dementia in later life. Thus, it is important to elucidate dietary approaches that benefit cognition. Lutein is a xanthophyll carotenoid thought to impact cognitive function. Daily consumption of avocado has been shown to improve cognitive function and lutein status but it is not clear whether these benefits extend to populations with overweight and obesity. Thus, we evaluated the influence of daily avocado consumption on cognitive function, serum lutein concentrations, and retinal xanthophyll status among adults with overweight and obesity using a randomized-controlled study. Methods Adults (N = 72, 25–45 years, 31 males) with overweight or obesity (BMI 25 kg/m2) were randomized to an intervention group (N = 38) that received a daily meal with one avocado or a control group (N = 34) that received an isocaloric meal without avocado for 12 weeks. Fasting serum lutein concentrations were evaluated through high-performance liquid chromatography. Macular pigment optical density (MPOD) was assessed through heterochromatic flicker photometry. Selective attention was assessed by a modified Flanker task. Results Group by time interactions were seen for serum lutein concentrations (P = 0.002) and flanker accuracy (P = 0.006) whereby the intervention group exhibited a more substantial increase in serum lutein concentrations (0.04 ug/ml; 95% CI, 0.02 to 0.06) and overall task accuracy (2.4%; 95% CI, 0.4 to 4.5). However, there was no relationship between task performance and changes in serum lutein concentration (P = 0.23), nor changes in MPOD. Conclusions Daily consumption of a meal containing avocado improved selective attention and serum lutein concentrations among adults with overweight and obesity. The cognitive benefits of avocado consumption were apparent even prior to changes in retinal lutein status. Given that avocados are comprised of a variety of nutrients, additional work is necessary to determine non-carotenoid dependent mechanisms by which avocados may impact cognitive function. Funding Sources This work was supported by funds from the Hass Avocado Board, the Department of Kinesiology and Community Health at the University of Illinois, and the USDA National Institute of Food and Agriculture, Hatch project 1009249.

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Virtual reality environment using a dome screen for procedural pain in young children during intravenous placement: A pilot randomized controlled trial

PLoS ONE ◽

10.1371/journal.pone.0256489 ◽

2021 ◽

Vol 16 (8) ◽

pp. e0256489

Author(s):

Ha Ni Lee ◽

Woori Bae ◽

Joong Wan Park ◽

Jae Yun Jung ◽

Soyun Hwang ◽

...

Keyword(s):

Virtual Reality ◽

Young Children ◽

Controlled Trial ◽

Intervention Group ◽

Pediatric Emergency ◽

Control Group ◽

Blood Collection ◽

Randomized Controlled ◽

The Difference ◽

Study Process

We assessed the feasibility and potential efficacy of a virtual reality (VR) environment using a dome screen as a distraction method in young children during intravenous (IV) placement in the pediatric emergency department. This randomized controlled pilot study enrolled children aged 2 to 6 years who underwent IV placement into either the intervention group or the control group. Children in the intervention group experienced VR using a dome screen during IV placement. The child’s pain intensity was measured using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale at four time points of IV placement: immediately after arrival to the blood collection room (base); immediately after the child laid down on the bed (preparation); when the tourniquet was applied (tourniquet); and the moment at which the needle penetrated the skin (venipuncture). The guardian’s satisfaction and rating of the child’s distress were assessed using a 5-point Likert-type questionnaire. We recruited 19 children (9 in the intervention group and 10 in the control group). Five children in the control group were excluded from the analysis because of missing video recordings (n = 3), failed first attempt at IV placement (n = 1), and the child’s refusal to lie on the bed during the procedure (n = 1). No side effects of VR were reported during the study period. Although the average FLACC scale score at each time point (preparation, tourniquet, venipuncture) was lower in the intervention group than the control group, the difference was not statistically significant (2.3, interquartile range [IQR]: 2.0–3.0; vs. 3.3, IQR: 2.7–6.7, P = 0.255). There were no statistically significant differences between the groups in the guardian’s satisfaction and anxiety or his/her rating of the child’s pain and anxiety. The guardians and emergency medical technicians reported satisfaction with the use of VR with a dome screen and considered it a useful distraction during the procedure. VR using a dome screen is a feasible distraction method for young children during IV placement. A larger clinical trial with further development of the VR environment and study process is required to adequately evaluate the efficacy of VR using a dome screen.

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Maternal low-intensity psychosocial telemental interventions in response to COVID-19 in Qatar: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05339-w ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Sarah Naja ◽

Rowaida Elyamani ◽

Mohamad Chehab ◽

Mohamed Siddig ◽

Abdullah Al Ibrahim ◽

...

Keyword(s):

Mental Health ◽

Pregnant Women ◽

Psychological Health ◽

Psychosocial Support ◽

Maternal Mental Health ◽

Controlled Trial ◽

Intervention Group ◽

Research Centre ◽

Control Group ◽

Low Intensity

Abstract Introduction As COVID-19 is spreading, new psychological health problems are suspected to be emerging among pregnant women. Higher maternal mental health distress, including perinatal anxiety, depression, and COVID-19-specific phobia, is supposed to be increasing during the pandemic, which impacts pregnant women’s health and their infants and calls for intervention. Due to the social distancing protocols posed by the pandemic, telemental health interventions have fast become the most common form of psychosocial support for maternal mental health. However, there is no evidence of the effectiveness of maternal low-intensity psychosocial telemental interventions in improving mental health outcomes. The trial’s objective is to evaluate the clinical efficacy of telemental low-intensity psychosocial interventions in pregnant and postpartum women attending the Women Wellness and Research Centre in Qatar in the era of the COVID-19 pandemic. Methods and analysis The clinical trial is randomized in which pregnant women will be assigned equally through block randomization between two arms: (1) a control group and (2) an intervention group. The primary endpoint is the perinatal psychological distress, including perinatal depression, anxiety, and COVID-19 phobia in their third trimester; the secondary, tertiary, fourth, and fifth endpoints will be in the postnatal period (3–5 weeks, 2–4 months, 5–7 months, and 8–10 months). This trial involves pregnant women in their second trimester with no mental health illness history who communicate in English and Arabic and consent to participate. A sample size of 58 (29 participants per arm) is targeted. Discussion This study will provide recommendations about the efficacy of low-intensity psychosocial maternal telemental interventions to be implemented as a preventive service. Trial registration 2a-ClinicalTrials.gov NCT04594525. Registered on October 20, 2020.

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Effects on Metabolic Health after a 1-Year-Lifestyle Intervention in Overweight and Obese Children: A Randomized Controlled Trial

Journal of Nutrition and Metabolism ◽

10.1155/2012/913965 ◽

2012 ◽

Vol 2012 ◽

pp. 1-10 ◽

Cited By ~ 6

Author(s):

Maria Waling ◽

Catharina Bäcklund ◽

Torbjörn Lind ◽

Christel Larsson

Keyword(s):

Controlled Trial ◽

Venous Blood ◽

Intervention Group ◽

Overweight And Obesity ◽

Lifestyle Changes ◽

Control Group ◽

Obese Children ◽

Metabolic Markers ◽

Significant Difference ◽

And Control

Objective.To evaluate the effect of a family-based intervention on anthropometric and metabolic markers in overweight and obese children.Methods.Overweight or obese 8–12 years olds (n= 93) were randomized into intervention or control groups. The intervention group participated in a program aiming for lifestyle changes regarding food habits and physical activity. Anthropometric measures and venous blood samples were collected from all children at baseline and after 1 year.Results.BMI z-scores decreased in both groups, 0.22 (P= 0.002) and 0.23 (P= 0.003) in intervention and control group, respectively, during the 1-year study, but there was no difference in BMI between the groups at 1-year measurement (P= 0.338). After 1 year, there was a significant difference in waist circumference, waist/hip ratio, and apolipoprotein B/A1 ratio between intervention and control group.Conclusions.The intervention had limited effects on anthropometrics and metabolic markers, which emphasizes the need of preventing childhood overweight and obesity.

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