Consumption of Dietary Guidelines for Americans Types and Amounts of Vegetables Increases Subjective Happiness: A Randomized Controlled Trial

Objectives The health benefits of diets rich in fruits and vegetables (FV) are well established and form the basis of the Dietary Guidelines for Americans (DGA). Furthermore, FV consumption may also exert a positive effect on psychological well-being. This study aimed to assess changes in global subjective happiness when consuming DGA recommended types and amounts of vegetables. It was hypothesized that increased vegetable consumption would increase happiness. Methods This study investigated secondary outcomes of a randomized, parallel, non-blinded controlled trial with a 1:1 allocation ratio to a provided vegetable intervention or attention control group. Men and women aged 18–65 yr, body mass index ≥ 25 kg/m,2 with low habitual vegetable consumption (<1 serving/day) were recruited for this community-based study. The vegetable intervention consisted of an 8-week feeding phase during which participants were provided with vegetables in DGA recommended types and amounts. The attention control group was not provided vegetables but completed the same testing schedule as the vegetable intervention group. The Subjective Happiness Scale (SHS) was used to assess individual perceived happiness before and after the intervention. SHS scores were analyzed using a mixed model analysis of variance both with and without baseline SHS scores as a covariate. Results A significant interaction between treatment and visit (P = 0.005) revealed greater happiness at week 8 than at baseline in the vegetable intervention group but no change in the attention control group. When adjusted for baseline scores, a significant effect of treatment (P = 0.005) was found with greater happiness scores in the vegetable intervention group compared to the attention control group post intervention (P < 0.001). Conclusions Greater subjective happiness was observed after increasing vegetable consumption to meet DGA recommendations. Funding Sources USDA-ARS #5450–51,530-057–00D.

Effectiveness of Smartphone-Based Mindfulness Training on Maternal Perinatal Depression: Randomized Controlled Trial

Background Despite potential for benefit, mindfulness remains an emergent area in perinatal mental health care, and evidence of smartphone-based mindfulness training for perinatal depression is especially limited. Objective The objective of this study was to evaluate the effectiveness of a smartphone-based mindfulness training intervention during pregnancy on perinatal depression and other mental health problems with a randomized controlled design. Methods Pregnant adult women who were potentially at risk of perinatal depression were recruited from an obstetrics clinic and randomized to a self-guided 8-week smartphone-based mindfulness training during pregnancy group or attention control group. Mental health indicators were surveyed over five time points through the postpartum period by online self-assessment. The assessor who collected the follow-up data was blind to the assignment. The primary outcome was depression as measured by symptoms, and secondary outcomes were anxiety, stress, affect, sleep, fatigue, memory, and fear. Results A total of 168 participants were randomly allocated to the mindfulness training (n=84) or attention control (n=84) group. The overall dropout rate was 34.5%, and 52.4% of the participants completed the intervention. Mindfulness training participants reported significant improvement of depression (group × time interaction χ24=16.2, P=.003) and secondary outcomes (χ24=13.1, P=.01 for anxiety; χ24=8.4, P=.04 for positive affect) compared to attention control group participants. Medium between-group effect sizes were found on depression and positive affect at postintervention, and on anxiety in late pregnancy (Cohen d=0.47, –0.49, and 0.46, respectively). Mindfulness training participants reported a decreased risk of positive depressive symptom (Edinburgh Postnatal Depression Scale [EPDS] score>9) compared to attention control participants postintervention (odds ratio [OR] 0.391, 95% CI 0.164-0.930) and significantly higher depression symptom remission with different EPDS reduction scores from preintervention to postintervention (OR 3.471-27.986). Parity did not show a significant moderating effect; however, for nulliparous women, mindfulness training participants had significantly improved depression symptoms compared to nulliparous attention control group participants (group × time interaction χ24=18.1, P=.001). Conclusions Smartphone-based mindfulness training is an effective intervention in improving maternal perinatal depression for those who are potentially at risk of perinatal depression in early pregnancy. Nulliparous women are a promising subgroup who may benefit more from mindfulness training. Trial Registration Chinese Clinical Trial Registry ChiCTR1900028521; http://www.chictr.org.cn/showproj.aspx?proj=33474

Physical Activity Adherence Rates in Older Kidney Transplant Recipients: A Pilot Randomized Controlled Trial

Daily walking activities are associated with improving cardiovascular and well-being in older kidney transplant recipients. Multicomponent interventions using technology and goal setting holds promise for sustaining daily walking activity among this population. The purpose of this randomized controlled trial pilot study was to evaluate the feasibility of a multicomponent intervention called SystemCHANGE™ + activity tracker for daily walking activity in older (age 60 and over) kidney recipients from baseline to 12 months. The intervention group implement a personal-system solution and wore a mobile activity tracker daily for 12 months. The attention-control group received educational information on healthy living as a transplant recipient and was asked to wear a mobile activity tracker daily for 12 months. Participants were randomized 1:1 to the intervention or control group. The sample consisted of 53 participants (n = 27 intervention, and n = 26 control). At the 12-month follow-up visit, the total study attrition rate was 23%. The adherence rates at 12 months were 96.5% in the intervention group and 80.8% in the attention- control group. The intervention group increased their steps from baseline to 12 months by 334 steps per day. The attention-control group demonstrated a decrease in steps by 563 steps per day. We found a mean difference of 1041± 2440 (Cohen’s d = 0.43) in daily steps between the groups from baseline to 12 months. The data suggests SystemCHANGE™ in combination with activity trackers may be feasible for older kidney transplant recipients to enhance and sustain physical activity with daily walking.

Effectiveness of Smartphone-Based Mindfulness Training on Maternal Perinatal Depression: Randomized Controlled Trial (Preprint)

BACKGROUND Despite potential for benefit, mindfulness remains an emergent area in perinatal mental health care, and evidence of smartphone-based mindfulness training for perinatal depression is especially limited. OBJECTIVE The objective of this study was to evaluate the effectiveness of a smartphone-based mindfulness training intervention during pregnancy on perinatal depression and other mental health problems with a randomized controlled design. METHODS Pregnant adult women who were potentially at risk of perinatal depression were recruited from an obstetrics clinic and randomized to a self-guided 8-week smartphone-based mindfulness training during pregnancy group or attention control group. Mental health indicators were surveyed over five time points through the postpartum period by online self-assessment. The assessor who collected the follow-up data was blind to the assignment. The primary outcome was depression as measured by symptoms, and secondary outcomes were anxiety, stress, affect, sleep, fatigue, memory, and fear. RESULTS A total of 168 participants were randomly allocated to the mindfulness training (n=84) or attention control (n=84) group. The overall dropout rate was 34.5%, and 52.4% of the participants completed the intervention. Mindfulness training participants reported significant improvement of depression (group × time interaction χ²₄=16.2, <i>P</i>=.003) and secondary outcomes (χ²₄=13.1, <i>P</i>=.01 for anxiety; χ²₄=8.4, <i>P</i>=.04 for positive affect) compared to attention control group participants. Medium between-group effect sizes were found on depression and positive affect at postintervention, and on anxiety in late pregnancy (Cohen d=0.47, –0.49, and 0.46, respectively). Mindfulness training participants reported a decreased risk of positive depressive symptom (Edinburgh Postnatal Depression Scale [EPDS] score&gt;9) compared to attention control participants postintervention (odds ratio [OR] 0.391, 95% CI 0.164-0.930) and significantly higher depression symptom remission with different EPDS reduction scores from preintervention to postintervention (OR 3.471-27.986). Parity did not show a significant moderating effect; however, for nulliparous women, mindfulness training participants had significantly improved depression symptoms compared to nulliparous attention control group participants (group × time interaction χ²₄=18.1, <i>P</i>=.001). CONCLUSIONS Smartphone-based mindfulness training is an effective intervention in improving maternal perinatal depression for those who are potentially at risk of perinatal depression in early pregnancy. Nulliparous women are a promising subgroup who may benefit more from mindfulness training. CLINICALTRIAL Chinese Clinical Trial Registry ChiCTR1900028521; http://www.chictr.org.cn/showproj.aspx?proj=33474

A cognitive behavioral therapy intervention to reduce fear of hypoglycemia in young adults with type 1 diabetes (FREE): study protocol for a randomized controlled trial

Background In persons with type 1 diabetes (T1D), hypoglycemia is the major limiting factor in achieving optimal glycemic control. All persons with T1D are at risk for hypoglycemia (blood glucose level < 70 mg/dl), which is life-threatening and accompanied by serious physical and psychological symptoms, resulting in profound fear of hypoglycemia (FOH) and reduced quality of life. Young adults with T1D are at risk for FOH and have worse glycemic control and self-management behavior than other age groups with T1D. FOH also results in increased glycemic variability (GV). A major gap exists in how to manage FOH. Our overall objective is to reduce FOH and improve diabetes self-management, glycemic control, and GV in young adults with T1D to reduce or delay diabetes complications and improve quality of life. We aim to (1) determine the feasibility and acceptability of an eight-week cognitive behavioral therapy (CBT)-based Fear Reduction Efficacy Evaluation (FREE) intervention in young adults with T1D who experience FOH; and (2) determine the impact of the FREE intervention, compared to an attention control group, on the outcomes FOH, self-management, glycemic control (A1C), and glycemic variability (continuous glucose monitoring recordings). Methods/design A randomized controlled trial in 50 young adults aged 18 to 35 years with T1D will be used. Eligible subjects will be randomized to the intervention program (Fear Reduction Efficacy Evaluation [FREE]) or attention control group. A one-week run-in phase is planned, with baseline measures of FOH, self-management behavior, A1C, and real-time continuous glucose monitoring recordings (RT-CGM) to calculate GV for both groups. The intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears. RT-CGM and a daily FOH diary will be used as feedback cues as part of the FREE program. The attention control group will participate in eight weekly individual one-hour diabetes self-management education (DSME) sessions and wear a RT-CGM device (to measure GV only) over 8 weeks. At completion, FOH will be measured, and RT-CGM recordings will be analyzed to determine differences between the FREE and control groups. Discussion Findings from this proposed pilot study will serve as the foundation for a larger trial to reduce FOH and improve self-management, glycemic control, and GV. Trial registration ClinicalTrials.gov: A cognitive behavioral therapy (CBT) intervention to reduce fear of hypoglycemia in type 1 diabetes, NCT03549104. Registered June 7, 2018

EFFECTIVENESS OF A SIMULATION-BASED EMPATHY ENHANCEMENT PROGRAM WITH MINDFULNESS ON SOCIAL WORKERS

Empathy enhancement programs and mindfulness-based practices may reduce care practitioners’ burnout and stress while increasing satisfaction, caring efficacy, and well-being. No study has been conducted to measure the effectiveness of a simulation-based empathy enhancement program combined with mindfulness practice on professionals working with older adults living alone. This study, therefore, assessed the effectiveness of a simulation-based empathy enhancement program with a brief mindfulness practice session on social workers working with older adults living alone. This study was a quasi-experimental study involving 105 social workers in South Korea. The experimental group received a simulation-based empathy enhancement program with mindfulness practice, and the attention control group watched a 30-minute-long educational video about empathy. Data were collected prior to the intervention and at two weeks after the intervention using self-reported questionnaires measuring empathy, caring efficacy, psychosocial stress, compassion satisfaction, burnout, and secondary traumatic stress. The experimental group had significantly lower levels of psychosocial stress compared to the attention control group. Both groups showed significant improvements in empathy but in different empathy measures. Also, the experimental group only showed significantly lower levels of burnout and secondary traumatic stress after the intervention while the attention control group only showed significant improvements in compassion satisfaction and caring efficacy. Although between-group differences were found in psychosocial stress only, pre-and post-test differences in different outcome measures from experimental and attention control groups indicate limited but possible effectiveness of each of the empathy enhancement programs on people in caring professionals.

Supporting Family Caregivers With Technology for Dementia Home Care: A Randomized Controlled Trial

Background and Objectives The number of persons living with dementia (PLWD) in the United States will reach 16 million by 2050. Behavioral and psychological symptoms of dementia challenge family caregivers and contribute to negative caregiver outcomes such as burden and depression. Available technology can support the delivery of effective interventions to families providing dementia care at home. The Supporting Family Caregivers with Technology for Dementia Home Care (FamTechCare) randomized controlled trial evaluated the effects of a telehealth intervention on caregiver outcomes. Research Design and Methods The FamTechCare intervention provides tailored dementia-care strategies to in-home caregivers based on video recordings caregivers submit of challenging care situations. An expert team reviews the videos and provides individualized interventions weekly for the experimental group. In the telephone-support attention control group, caregivers receive feedback from an interventionist via the telephone based on caregiver retrospective recall of care challenges. Effects of the intervention on caregiver outcomes, including burden, depression, sleep disturbance, competence, desire to institutionalize the PLWD, and caregiver reaction to behavioral symptoms were evaluated by fitting linear mixed regression models to changes in the outcomes measured at 1 and 3 months. Results FamTechCare caregivers (n = 42) had greater reductions in depression (p = .012) and gains in competence (p = .033) after 3 months compared to the attention control group (n = 41). Living in rural areas was associated with a reduction in depression for FamTechCare caregivers (p = .002). Higher level of education was associated with greater improvements or lesser declines in burden, competence, and reaction to behavioral symptoms for both the FamTechCare and attention control caregivers. Discussion and Implications This research demonstrated benefits of using available technology to link families to dementia care experts using video-recording technology. It provides a foundation for future research testing telehealth interventions, tailored based on rich contextual data to support families, including those in rural or remote locations.

Home-based Intervention Among Non-Hispanic Black Families Finds No Significant Difference in Growth at 15 Months: Results from the ‘Mothers & Others’ Randomized Trial (P04-187-19)

Objectives Mothers and Others (M&O) was an efficacy trial of a home-based intervention designed to prevent obesity in the first year of life. The primary outcome was infant growth, as assessed by differences in weight-for-age z-scores (WAZ) between the obesity prevention group and an attention-control group on infant safety. Methods The study design was a two-group randomized control trial among 428 non-Hispanic black (NHB) women recruited at 28 weeks’ pregnancy. The primary delivery channel for both groups was 6 home visits by a peer educator (PE). Mothers in the intervention group received anticipatory guidance (AG) on infant feeding and care behaviors related to obesity prevention. Mothers in the attention-control group received AG on child safety. Mothers in both groups identified a study partner, with partners in the control group only completing study assessments. Infant weight was assessed at birth by maternal self-report and at 3, 6, 9, 12 and 15 months of age by direct measurement. Infant WAZ scores were created using the World Health Organization 2006 international growth standards. The primary efficacy analysis was a linear mixed model (LMM) on an intention-to-treat (ITT) dataset with WAZ score at birth, 3, 6, 9, 12 and 15 months as the dependent variable and treatment group, age and their interaction term as the independent variables. Results Enrolled women were 25.76 ± 5.3 years at baseline and the majority were single (72.3%), receiving Medicaid (74.4%), and expecting their first child (56.1%). Baseline characteristics and visit completion rates did not differ by treatment group. At all time points, infants in the intervention group were smaller than those in the control group (e.g., mean WAZ at 15 months was 0.39 ± 1.04 among intervention infants and 0.53 ± 1.07 among control infants), but these differences were not significant. Results of the primary efficacy model yielded no difference in WAZ between infants in the two groups (beta for intervention = −.07, P = 0.659). Conclusions M&O was designed to fill several gaps in early life obesity prevention trials at the time of its inception, including a focus on infant temperament and inclusion of support partners. Despite rich preliminary data and a strong conceptual model, the intervention did not produce a significant difference in infant growth. Funding Sources National Institute of Diabetes and Digestive and Kidney Diseases.