-
1.
Effect of a Parent-Focused eHealth Intervention on Children's Fruit, Vegetable, and Discretionary Food Intake (Food4toddlers): Randomized Controlled Trial.
Røed, M, Medin, AC, Vik, FN, Hillesund, ER, Van Lippevelde, W, Campbell, K, Øverby, NC
Journal of medical Internet research. 2021;23(2):e18311
-
-
-
Free full text
Plain language summary
Diet in childhood tends to reflect that in adolescence and adulthood and so healthy eating habits established during this time may prevent increased weight, non-communicable diseases and even cancer. Healthy diet promotion to parents may be able to ensure that a healthy food environment is established, which will then continue throughout life. This randomised controlled trial of 404 parents aimed to determine the effect of parent-focused healthy food promotion via the internet for 12 months. The results showed that after 6 months that frequency of vegetable intake increased but this was not seen at 12 months. No differences were seen in the frequency of intake of sweet foods at either time point. It was concluded that intervention through a web-based healthy diet programme increased vegetable intake in the short-term, however in the long-term a personalised intervention or reminders may be needed. This study could be used by healthcare professionals to understand the importance of establishing a healthy diet from a young age and that parental support may be required to do this.
Abstract
BACKGROUND In Western countries, children's diets are often low in fruits and vegetables and high in discretionary foods. Diet in early life tends to track through childhood and youth and even into adulthood. Interventions should, therefore, be delivered in periods when habitual traits are established, as in toddlerhood when children adapt to their family's diet. OBJECTIVE In this study, we assessed the effect of the Food4toddlers eHealth intervention, which aimed to enhance toddlers' diets by shaping their food and eating environment. METHODS The Food4toddlers randomized controlled trial was conducted in Norway in 2017-2018. Parent-child dyads were recruited through social media. In total, 298 parents completed an online questionnaire at baseline (mean child age 10.9 months, SD 1.2). Postintervention questionnaires were completed immediately after the intervention (ie, follow-up 1; mean child age 17.8 months, SD 1.3) and 6 months after the intervention (ie, follow-up 2; mean child age 24.2 months, SD 1.9). The intervention was guided by social cognitive theory, which targets the linked relationship between the person, the behavior, and the environment. The intervention group (148/298, 49.7%) got access to the Food4toddlers website for 6 months from baseline. The website included information on diet and on how to create a healthy food and eating environment as well as activities, recipes, and collaboration opportunities. To assess intervention effects on child diet from baseline to follow-up 1 and from baseline to follow-up 2, we used generalized estimating equations and a time × group interaction term. Between-group differences in changes over time for frequency and variety of fruits and vegetables and frequency of discretionary foods were assessed. RESULTS At follow-up 1, a significant time × group interaction was observed for the frequency of vegetable intake (P=.02). The difference between groups in the change from baseline to follow-up 1 was 0.46 vegetable items per day (95% CI 0.06-0.86) in favor of the intervention group. No other significant between-group differences in dietary changes from baseline to follow-up 1 or follow-up 2 were observed. However, there is a clear time trend showing that the intake of discretionary foods increases by time from less than 1 item per week at baseline to more than 4 items per week at 2 years of age (P<.001), regardless of group. CONCLUSIONS A positive intervention effect was observed for the frequency of vegetable intake at follow-up 1 but not at follow-up 2. No other between-group effects on diet were observed. eHealth interventions of longer duration, including reminders after the main content of the intervention has been delivered, may be needed to obtain long-terms effects, along with tailoring in a digital or a personal form. TRIAL REGISTRATION International Standard Randomized Controlled Trial Number (ISRCTN) 92980420; https://doi.org/10.1186/ISRCTN92980420.
-
2.
Digital messaging to support control for type 2 diabetes (StAR2D): a multicentre randomised controlled trial.
Farmer, A, Bobrow, K, Leon, N, Williams, N, Phiri, E, Namadingo, H, Cooper, S, Prince, J, Crampin, A, Besada, D, et al
BMC public health. 2021;21(1):1907
-
-
-
Free full text
Plain language summary
Many individuals with type 2 diabetes find it challenging to adhere to treatments possibly due to lack of support. Text messaging has been shown to be effective for treatment adherence in various parts of the world, yet it is unclear on its effect in Malawi and sub-Saharan Africa. The aim of this randomised control trial of 1186 individuals was to determine the effect of motivational and educational text messages three to four times per week for 12 months on treatment success. The results showed that SMS text messages resulted in improved blood pressure and achievement of treatment goals, yet no effect on blood sugar control. It was concluded that text messaging without other support from health care professionals may be inadequate for the self-management of type 2 diabetes. This study could be used by health care professionals to understand that there are additional support strategies for individuals with type 2 diabetes, yet these should be secondary to the input from professionals.
Abstract
BACKGROUND Failure to take medicines for diabetes as prescribed contributes to poor outcomes from the condition. Mobile phones are ubiquitous and short message service (SMS) texts have shown promise as a low-cost intervention. We tested the effectiveness of SMS-text messaging in improving outcomes in adults with type 2 diabetes. METHODS StAR2D was a 12-month two-arm randomised trial of SMS-text messaging and usual care in Cape Town, South Africa and Lilongwe, Malawi. Messages used behaviour change theory and were developed with patients and staff. The intervention group received four messages each week. The primary outcome was change in HbA1c. Secondary outcomes were the proportion of patients who collected > 80% medication and changes in systolic blood pressure, lipids, cardiovascular risk, and the proportion of the participants reaching treatment goals. RESULTS The trial took place between 1 October, 2016 and 1 October 2018, 1186 participants were randomised to intervention (593) and control (593) groups. 91% of participants completed follow-up. There was a reduction in HbA1c (DCCT) in both groups but not in mean change (95% CI) between groups (- 0.08% (- 0.31 to 0.16) (IFCC - 0.82 mmol/mol (- 3.44 to 1.79). There was a small but not significant increase in the proportions of participants likely to have collected 80% or more of medication (Relative risk 1.11 (0.84 to 1.47; P = 0.47). There was a significant difference between groups in change in systolic blood pressure from baseline of 3.46 mmHg (1.48 to 5.44, P = 0.001) in favour of the intervention group. The between group difference in change in 10-year risk of coronary heart disease was - 0.71% (- 1.46 to 0.04, P = 0.064). The proportion of participants meeting treatment goals in the intervention group was 36.0% and in the control group 26.8% (Relative risk 1.36 (1.13 to 1.63, P = 0.001). Participants reported many challenges to adherence despite finding messages acceptable and useful. CONCLUSIONS Whilst SMS text messages do not lead to improved glycaemia in these low-resource settings there appeared to be an impact on blood pressure and achievement of treatment goals but the mechanisms for this are unclear. Text messages alone, may be unsuccessful unless accompanied by health system strengthening and other forms of self-management support for type 2 diabetes. TRIAL REGISTRATION Trial registration: ISRCTN, ISRCTN70768808. Registered 1 July 2015, http://www.isrctn.com/I ISRCTN70768808.
-
3.
Effect of a family and interdisciplinary intervention to prevent T2D: randomized clinical trial.
Vargas-Ortiz, K, Lira-Mendiola, G, Gómez-Navarro, CM, Padilla-Estrada, K, Angulo-Romero, F, Hernández-Márquez, JM, Villa-Martínez, AK, González-Mena, JN, Macías-Cervantes, MH, Reyes-Escogido, ML, et al
BMC public health. 2020;20(1):97
-
-
-
Free full text
Plain language summary
In individuals at high risk of type 2 diabetes, lifestyle interventions rather than medication have been more successful in preventing development of the disease, however the benefits of lifestyle strategies diminishes over time due to possible adherence issues. Prolonged lifestyle changes may be affected by lack of family support, but research on family support during lifestyle changes in individuals prior to diabetes is lacking. This parallel randomised control trial of 122 patients with prediabetes and 101 of their family members aimed to assess the impact of family supported diet and exercise changes compared to self-motivation on individuals with prediabetes. At 6 months, body measurements and markers of prediabetes improved in both groups. Lipids were significantly improved in the group with family support compared to having no support. At 12 months there were a high number of dropouts due to lack of patient interest. Benefits shown at 6 months in both groups were only maintained or improved upon with family support and the lipid profile of the individual intervention group actually worsened in comparison to when participants entered the trial. After 12 months the incidence rate of type 2 diabetes was similar in both groups. Individuals with prediabetes who had family support whilst undergoing a diet and exercise regime were more successful at maintaining improvements of factors contributing to diabetes, compared to individuals without support. However this did not affect the occurrence of type 2 diabetes. Clinicians could use this paper to communicate the importance of family support during lifestyle changes in patients at high risk of developing type 2 diabetes, although close monitoring may be required to ensure compliance.
Abstract
BACKGROUND Lifestyle changes can reduce the risk of T2D; however, no study has evaluated the effect of a lifestyle intervention involving patients´ family. The aim of this study was to compare the impact of an interdisciplinary family (FI) Vs individual intervention (II) on glucose metabolism, insulin resistance (IR), pancreatic β-cell function and cardiovascular risk markers in patients with prediabetes, as well as to measure the impact on their families' metabolic risk. METHODS Randomized Clinical Trial (RCT) to compare the impact of FI and II on IR and pancreatic β-cell function in subjects with prediabetes. There were 122 subjects with prediabetes (and 101 family members) randomized to FI or II. Data were collected in 2015-2016 and analyzed in 2017-2018. FI group had the support of their family members, who also received personalized diet and exercise recommendations; patients and their family members attended monthly a lifestyle enhancement program. II group received personalized diet and exercise recommendations. The follow-up was for 12 months. Glucose, IR, pancreatic β-cell function and secondary outcomes (body composition and lipid profile) were assessed at baseline, 6 and 12 months. RESULTS FI group improved area under the glucose curve (AUC) (from 18,597 ± 2611 to 17,237 ± 2792, p = 0.004) and the Matsuda index (from 3.5 ± 2.3 to 4.7 ± 3.5, p = 0.05) at 12 months. II group improved Disposition Index (from 1.5 ± 0.4 to 1.9 ± 0.73, p < .0001) at 12 months. The improvements achieved in weight and lipids at 6 months, were lost in II group at 12 moths, whereas in FI persisted. Adherence up to 12 months was not different between the study groups (FI 56% Vs II 60%). CONCLUSIONS FI intervention was more effective by improving glucose AUC, insulin sensitivity and lipid profile, besides that, metabolic risk in family members of the FI group was maintained, while the risk of II group was increased. TRIAL REGISTRATION This study was retrospectively registered at clinicaltrials.gov on December 15, 2015 (NTC026365646).
-
4.
Effects of the Healthy Children, Healthy Families, Healthy Communities Program for Obesity Prevention among Vulnerable Children: A Cluster-Randomized Controlled Trial.
Choo, J, Yang, HM, Jae, SY, Kim, HJ, You, J, Lee, J
International journal of environmental research and public health. 2020;17(8)
-
-
-
Free full text
Plain language summary
Childhood obesity is especially pronounced in those from lower socioeconomical backgrounds. The Three-Healthy Programme is a multilevel initiative designed to target obesity in these children. This randomised control trial of 104 socioeconomically vulnerable children and 59 of their parents over 12 weeks aimed to determine the effects of the Three-Healthy Programme on healthy lifestyle behaviours and obesity in children in the public welfare system. The results showed that the Three-Healthy Programme, which targeted child behavioural strategies, parenting strategies and organisational strategies helped to increase a child’s knowledge of healthy lifestyle behaviours, vegetable intake and physical activity. However, there were no improvements in breakfast, fruit, milk, no-sugar beverage and fast-food consumption. This did not translate to improved obesity status. It was concluded that the Three-Healthy Programme may be effective at promoting healthy lifestyles in socioeconomically vulnerable children. The short study duration may be the reason why obesity did not improve, at least one year of intervention may be needed. This study could be used by healthcare professionals to understand the importance of targeting all influencers for weight loss in children from socioeconomically vulnerable backgrounds.
Abstract
Background: We aimed to examine whether the Healthy Children, Healthy Families, and Healthy Communities Program, consisting of multi-level strategies for obesity prevention tailoring the context of socioeconomically vulnerable children based on an ecological perspective, would be effective on improving their healthy lifestyle behaviors and obesity status. Methods: Participants were 104 children (and 59 parents) enrolled in public welfare systems in Seoul, South Korea. Based on a cluster-randomized controlled trial (no. ISRCTN11347525), eight centers were randomly assigned to intervention (four centers, 49 children, 27 parents) versus control groups (four centers, 55 children, 32 parents). Multi-level interventions of child-, parent-, and center-level strategies were conducted for 12 weeks. Children's healthy lifestyle behaviors and obesity status were assessed as daily recommended levels and body mass index ≥85th percentile, respectively. Parents' parenting behaviors were measured by the Family Nutrition and Physical Activity scale. Results: Compared to the control group, the intervention group showed significant improvements in total composite scores of healthy-lifestyle behaviors-including 60-min of moderate physical activity-but not in obesity status among children. Moreover, the intervention group showed significant improvements in parenting behaviors among parents. Conclusion: The multi-level strategies for obesity prevention based on an ecological perspective may be effective for promoting healthy lifestyles among socioeconomically vulnerable children.
-
5.
Effect of a Comprehensive Cardiovascular Risk Reduction Intervention in Persons With Serious Mental Illness: A Randomized Clinical Trial.
Daumit, GL, Dalcin, AT, Dickerson, FB, Miller, ER, Evins, AE, Cather, C, Jerome, GJ, Young, DR, Charleston, JB, Gennusa, JV, et al
JAMA network open. 2020;3(6):e207247
-
-
-
Free full text
-
Plain language summary
Heart disease death rates in individuals with serious mental illness are double that of the general population, indicating a concerted effort is needed to help this group of people. However, previous studies on interventions have failed to show improvements indicating a requirement to identify effective solutions. This randomised control trial of 269 individuals with mental illness aimed to determine the effectiveness of an 18-month management plan to reduce heart disease risk. The results showed that heart disease risk was significantly decreased when individuals with mental illness were in a closely monitored management programme. This programme consisted of behavioural counselling and care coordination. It was concluded that a multi-faceted care management plan can significantly reduce the risk of heart disease in individuals with serious mental illness. This study could be used by health care professionals to understand that individuals with mental illness are at a higher risk of death from heart disease and that they need to consider enrolling them into a closely monitored management plan.
Abstract
Importance: Persons with serious mental illness have a cardiovascular disease mortality rate more than twice that of the overall population. Meaningful cardiovascular risk reduction requires targeted efforts in this population, who often have psychiatric symptoms and cognitive impairment. Objective: To determine the effectiveness of an 18-month multifaceted intervention incorporating behavioral counseling, care coordination, and care management for overall cardiovascular risk reduction in adults with serious mental illness. Design, Setting, and Participants: This randomized clinical trial was conducted from December 2013 to November 2018 at 4 community mental health outpatient programs in Maryland. The study recruited adults with at least 1 cardiovascular disease risk factor (hypertension, diabetes, dyslipidemia, current tobacco smoking, and/or overweight or obesity) attending the mental health programs. Of 398 participants screened, 269 were randomized to intervention (132 participants) or control (137 participants). Data collection staff were blinded to group assignment. Data were analyzed on the principle of intention to treat, and data analysis was performed from November 2018 to March 2019. Interventions: A health coach and nurse provided individually tailored cardiovascular disease risk reduction behavioral counseling, collaborated with physicians to implement appropriate risk factor management, and coordinated with mental health staff to encourage attainment of health goals. Programs offered physical activity classes and received consultation on serving healthier meals; intervention and control participants were exposed to these environmental changes. Main Outcomes and Measures: The primary outcome was the change in the risk of cardiovascular disease from the global Framingham Risk Score (FRS), which estimates the 10-year probability of a cardiovascular disease event, from baseline to 18 months, expressed as percentage change for intervention compared with control. Results: Of 269 participants randomized (mean [SD] age, 48.8 [11.9] years; 128 men [47.6%]), 159 (59.1%) had a diagnosis of schizophrenia or schizoaffective disorder, 67 (24.9%) had bipolar disorder, and 38 (14.1%) had major depressive disorder. At 18 months, the primary outcome, FRS, was obtained for 256 participants (95.2%). The mean (SD) baseline FRS was 11.5% (11.5%) (median, 8.6%; interquartile range, 3.9%-16.0%) in the intervention group and 12.7% (12.7%) (median, 9.1%; interquartile range, 4.0%-16.7%) in the control group. At 18 months, the mean (SD) FRS was 9.9% (10.2%) (median, 7.7%; interquartile range, 3.1%-12.0%) in the intervention group and 12.3% (12.0%) (median, 9.7%; interquartile range, 4.0%-15.9%) in the control group. Compared with the control group, the intervention group experienced a 12.7% (95% CI, 2.5%-22.9%; P = .02) relative reduction in FRS at 18 months. Conclusions and Relevance: An 18-month behavioral counseling, care coordination, and care management intervention statistically significantly reduced overall cardiovascular disease risk in adults with serious mental illness. This intervention provides the means to substantially reduce health disparities in this high-risk population. Trial Registration: ClinicalTrials.gov Identifier: NCT02127671.
-
6.
Exercise as adjunctive treatment for alcohol use disorder: A randomized controlled trial.
Roessler, KK, Bilberg, R, Søgaard Nielsen, A, Jensen, K, Ekstrøm, CT, Sari, S
PloS one. 2017;12(10):e0186076
-
-
-
Free full text
Plain language summary
Treating alcohol-use disorder (AUD) is challenging and multi-faceted thus many analyses suggest the effectiveness of interventions be low. Recent evidence suggests exercise may be a promising addition to intervention in both reducing consumption as well as the co-morbidities linked with AUD. The aim of this study was to evaluate the efficacy of physical activity as an adjunct to outpatient alcohol treatment on alcohol consumption in 100 patients. Participants were allocated to one of three arms: treatment, treatment with group exercise or treatment with individual exercise, and alcohol intake was measured at six and 12 months after treatment initiation. This study demonstrated that there is no significant effect of physical activity on alcohol consumption, however moderate physical activity was seen to be protective against excessive drinking following treatment. Based on this study as well as the Health Lifestyle Study, the authors support the need for implementing physically active lifestyles for patients in treatment.
Abstract
AIMS: To examine whether physical activity as an adjunct to outpatient alcohol treatment has an effect on alcohol consumption following participation in an exercise intervention of six months' duration, and at 12 months after treatment initiation. METHODS The study is a randomized controlled study with three arms: Patients allocated to (A) treatment as usual, (B) treatment as usual and supervised group exercise, (C) treatment as usual and individual physical exercise. The primary outcome measure was excessive drinking six months after treatment start and completion of the intervention. A logistic regression model was used to evaluate the odds of excessive drinking among the three groups, based on intention-to-treat. Changes in level of physical activity in all three groups were tested by using a generalized linear mixed model. A multiple linear model was used to test if there was an association between amount of performed physical activity and alcohol consumption. RESULTS A total of 175 patients (68.6% male) participated. Response rates were 77.7% at six months and 57.1% at 12 months follow-up. OR 0.99 [95% CI: 0.46; 2.14], p = 0.976 for excessive drinking in the group exercise condition, and 1.02 [95% CI: 0.47; 2.18], p = 0.968 in the individual exercise condition, which, when compared to the control group as reference, did not differ statistically significantly. Participants with moderate level physical activity had lower odds for excessive drinking OR = 0.12 [0.05; 0.31], p<0.001 than participants with low level physical activity. Amount of alcohol consumption in the intervention groups decreased by 4% [95% CI: 0.03; 6.8], p = 0.015 for each increased exercising day. CONCLUSIONS No direct effect of physical exercise on drinking outcome was found. Moderate level physical activity was protective against excessive drinking following treatment. A dose-response effect of exercise on drinking outcome supports the need for implementing physically active lifestyles for patients in treatment for alcohol use disorder.