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Filipinos Fit and Trim - A feasible and efficacious DPP-based intervention trial.

ABSTRACT: Introduction:Filipino Americans are at higher risk for obesity and related Type 2 diabetes (T2D) compared to other Asian subgroups and non-Hispanic whites. Yet, there are limited research studies to reduce health disparities and improve health outcomes for Filipinos. Weight loss lifestyle intervention trials such as the Diabetes Prevention Program (DPP) can reduce obesity and T2D risks through physical activity and healthy eating. Methods:Thus, we conducted a pilot Fit&Trim (DPP-based) intervention study - a randomized controlled trial 3-month intervention augmented with mobile technology + 3-month maintenance follow-up with a waitlist control. The objective assessed the intervention feasibility and potential efficacy to reduce T2D risks in Filipino Americans with overweight/obesity. The overall study goal was a mean 5% weight reduction. Results:Sixty-seven eligible Filipino men and women were enrolled and randomized to either an intervention or waitlist control group. Participant retention was 91%. In Phase 1 (baseline to 3-months), the intervention group had greater weight reduction compared to the waitlist control (-4.3% vs. -0.88%; cross-level interaction?=?-0.85 (-1.4, -0.35). In Phase 2 (3- to 6-months), after receiving the Fit&Trim intervention, the waitlist group also had similar significant weight reduction [-4.8% (- 0.75 (-0.92, -0.58)]. A majority of intervention group (57%) also maintained their weight loss. Overall, 41% of study participants achieved a 5% weight loss. Conclusion:The Fit&Trim intervention demonstrated feasibility and potential efficacy for Filipino Americans. Findings warrant a further larger, longer trial to test the Fit&Trim feasibility and effectiveness in a real-world Filipino community setting. ClinicalTrialsgov registration number:NCT02278939.

SUBMITTER: Bender MS

PROVIDER: S-EPMC6170935 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Filipinos Fit and Trim - A feasible and efficacious DPP-based intervention trial.

Bender Melinda S MS Cooper Bruce A BA Flowers Elena E Ma Raymond R Arai Shoshana S

Contemporary clinical trials communications 20180920

<h4>Introduction</h4>Filipino Americans are at higher risk for obesity and related Type 2 diabetes (T2D) compared to other Asian subgroups and non-Hispanic whites. Yet, there are limited research studies to reduce health disparities and improve health outcomes for Filipinos. Weight loss lifestyle intervention trials such as the Diabetes Prevention Program (DPP) can reduce obesity and T2D risks through physical activity and healthy eating.<h4>Methods</h4>Thus, we conducted a pilot Fit&Trim (DPP-b ...[more]

PMID: 30294699

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Project description:BackgroundFilipino Americans have a high prevalence of obesity, type 2 diabetes (T2D), and cardiovascular disease compared with other Asian American subgroups and non-Hispanic whites. Mobile health (mHealth) weight loss interventions can reduce chronic disease risks, but these are untested in Filipino Americans with T2D.ObjectiveThe objective of this study was to assess feasibility and potential efficacy of a pilot, randomized controlled trial (RCT) of a culturally adapted mHealth weight loss lifestyle intervention (Pilipino Americans Go4Health [PilAm Go4Health]) for overweight Filipino Americans with T2D.MethodsThis was a 2-arm pilot RCT of the 3-month PilAm Go4Health intervention (phase 1) with an active waitlist control and 3-month follow-up (phase 2). The waitlist control received the PilAm Go4Health in phase 2, whereas the intervention group transitioned to the 3-month follow-up. PilAm Go4Health incorporated a Fitbit accelerometer, mobile app with diary for health behavior tracking (steps, food/calories, and weight), and social media (Facebook) for virtual social support, including 7 in-person monthly meetings. Filipino American adults ≥18 years with T2D were recruited from Northern California. Feasibility was measured by rates of recruitment, engagement, and retention. Multilevel regression analyses assessed within and between group differences for the secondary outcome of percent weight change and other outcomes of weight (kg), body mass index (BMI), waist circumference, fasting plasma glucose, HbA1c, and steps.ResultsA total of 45 Filipino American adults were enrolled and randomized. Mean age was 58 (SD 10) years, 62% (28/45) were women, and mean BMI was 30.1 (SD 4.6). Participant retention and study completion were 100%, with both the intervention and waitlist group achieving near-perfect attendance at all 7 intervention office visits. Groups receiving the PilAm Go4Health in phase 1 (intervention group) and phase 2 (waitlist group) had significantly greater weight loss, -2.6% (-3.9 to -1.4) and -3.3% (-1.8 to -4.8), respectively, compared with the nonintervention group, resulting in a moderate to small effect sizes (d=0.53 and 0.37, respectively). In phase 1, 18% (4/22) of the intervention group achieved a 5% weight loss, whereas 82% (18/22) maintained or lost 2% to 5% of their weight and continued to maintain this weight loss in the 3-month follow-up. Other health outcomes, including waist circumference, BMI, and step counts, improved when each arm received the PilAm Go4Health, but the fasting glucose and HbA1c outcomes were mixed.ConclusionsThe PilAm Go4Health was feasible and demonstrated potential efficacy in reducing diabetes risks in overweight Filipino Americans with T2D. This study supports the use of mHealth and other promising intervention strategies to reduce obesity and diabetes risks in Filipino Americans. Further testing in a full-scale RCT is warranted. These findings may support intervention translation to reduce diabetes risks in other at-risk diverse populations.Trial registrationClinicaltrials.gov NCT02290184; https://clinicaltrials.gov/ct2/show/NCT02290184 (Archived by WebCite at http://www.webcitation.org/6vDfrvIPp).

Project description:High-Intensity Interval Training (HIIT) involves bursts of high-intensity exercise interspersed with lower-intensity exercise recovery. HIIT may benefit cardiometabolic health in people with nonalcoholic steatohepatitis (NASH). We aimed to examine the safety, feasibility, and efficacy of 12-weeks of supervised HIIT compared with a sham-exercise control (CON) for improving aerobic fitness and peripheral insulin sensitivity in biopsy-proven NASH. Participants based in the community [(n = 14, 56 ± 10 years, BMI 39.2 ± 6.7 kg/m2, 64% male), NAFLD Activity Score 5 (range 3-7)] were randomized to 12-weeks of supervised HIIT (n = 8, 4 × 4 min at 85-95% maximal heart rate, interspersed with 3 min active recovery; 3 days/week) or CON (n = 6, stretching; 3 days/week). Safety (adverse events) and feasibility determined as ≥ 70% program completion and ≥ 70% global adherence (including session attendance, interval intensity adherence, and duration adherence) were assessed. Changes in cardiorespiratory fitness (V̇O2peak), exercise capacity (time-on-test) and peripheral insulin sensitivity (euglycemic hyperinsulinemic clamp) were assessed. Data were analysed using ANCOVA with baseline value as the covariate. There were no HIIT-related adverse events and HIIT was globally feasible [program completion 75%, global adherence 100% (including adherence to session 95.4 ± 7.3%, interval intensity 95.3 ± 6.0% and duration 96.8 ± 2.4%)]. A large between-group effect was observed for exercise capacity [mean difference 134.2 s (95% CI 19.8, 248.6 s), ƞ2 0.44, p = 0.03], improving in HIIT (106.2 ± 97.5 s) but not CON (- 33.4 ± 43.3 s), and for peripheral insulin sensitivity [mean difference 3.4 mg/KgLegFFM/min (95% CI 0.9,6.8 mg/KgLegFFM/min), ƞ2 0.32, p = 0.046], improving in HIIT (1.0 ± 0.8 mg/KgLegFFM/min) but not CON (- 3.1 ± 1.2 mg/KgLegFFM/min). HIIT is safe, feasible and efficacious for improving exercise capacity and peripheral insulin sensitivity in people with NASH. Australian New Zealand Clinical Trial Registry (anzctr.org.au) identifier ACTRN12616000305426 (09/03/2016).

Project description:Only 5% of Canadian youth meet the recommended 60 minutes of moderate to vigorous physical activity (MVPA) per day, with leisure time being increasingly allocated to technology usage. Direct-to-consumer mHealth devices that promote physical activity, such as wrist-worn physical activity trackers, have features with potential appeal to youth.The primary purpose of this study was to determine whether a minimalist physical activity tracker-based intervention would lead to an increase in physical activity in young adolescents. A secondary aim of this study was to assess change in physical activity across a 7-week intervention, as measured by the tracker.Using a quasi-experimental crossover design, two groups of 23 young adolescents (aged 13-14 years) were randomly assigned to immediate intervention or delayed intervention. The intervention consisted of wearing a Fitbit-Charge-HR physical activity tracker over a 7-week period. Actical accelerometers were used to measure participants' levels of MVPA before and at the end of intervention periods for each group. Covariates such as age, sex, stage of change for physical activity behavior, and goal commitment were also measured.There was an increase in physical activity over the course of the study period, though it was not related to overall physical activity tracker use. An intervention response did, however, occur in a subset of participants. Specifically, exposure to the physical activity tracker was associated with an average daily increase in MVPA by more than 15 minutes (P=.01) among participants who reported being in the action and maintenance stages of behavior change in relation to participation in physical activity. Participants in the precontemplation, contemplation, and preparation stages of behavior change had no change in their level of MVPA (P=.81).These results suggest that physical activity trackers may elicit improved physical activity related behavior in young adolescents demonstrating a readiness to be active. Future studies should seek to investigate if integrating physical activity trackers as part of more intensive interventions leads to greater increases in physical activity across different levels of stages of behavior change and if these changes can be sustained over longer periods of time.

Project description:BackgroundPeople spend large parts of their everyday life using their smartphones. Despite various advantages of the smartphone for daily life, problematic forms of smartphone use exist that are related to negative psychological and physiological consequences. To reduce problematic smartphone use, existing interventions are oftentimes app-based and include components that help users to monitor and restrict their smartphone use by setting timers and blockers. These kinds of digital detox interventions, however, fail to exploit psychological resources, such as through promoting self-efficacious and goal-directed smartphone use.ObjectiveThe aim of this study is to evaluate the theory-based smartphone app "Not Less But Better" that was developed to make people aware of psychological processes while using the smartphone and to support them in using their smartphone in accordance with their goals and values.MethodsIn a randomized controlled trial, effects of a 20-day intervention app consisting of five 4-day training modules to foster a goal-directed smartphone use were evaluated. In the active control condition (treatment as usual), participants received a digital detox treatment and planned daily time-outs of at least 1 hour per day. Up to a 3-week follow-up, self-reported problematic smartphone use, objectively measured daily smartphone unlocks, time of smartphone use, self-efficacy, and planning towards goal-directed smartphone use were assessed repeatedly. Linear 2-level models tested intervention effects. Mediation models served to analyze self-efficacy and planning as potential mechanisms of the intervention.ResultsOut of 232 enrolled participants, 110 (47.4%; 55 participants in each condition) provided data at postintervention and 88 (37.9%; 44 participants in each condition) at 3-week follow-up. Both conditions manifested substantial reductions in problematic smartphone use and in the amount of time spent with the smartphone. The number of daily unlocks did not change over time. Further, modelling changes in self-efficacy as a mediator between the intervention and problematic smartphone use at follow-up fit well to the data and showed an indirect effect (b=-0.09; 95% bias-corrected bootstrap CI -0.26 to -0.01), indicating that self-efficacy was an important intervention mechanism. Another mediation model revealed an indirect effect from changes in planning via smartphone unlocks at postintervention on problematic smartphone use at follow-up (b=-0.029, 95% bias-corrected bootstrap CI -0.078 to -0.003).ConclusionsAn innovative, theory-based intervention app on goal-directed smartphone use has been found useful in lowering problematic smartphone use and time spent with the smartphone. However, observed reductions in both outcomes were not superior to the active control condition (ie, digital detox treatment). Nonetheless, the present findings highlight the importance in promoting self-efficacy and planning goal-directed smartphone use to achieve improvements in problematic smartphone use. This scalable intervention app appears suitable for practical use and as an alternative to common digital detox apps. Future studies should address issues of high attrition by adding just-in-time procedures matched to smartphone users' needs.Trial registrationGerman Clinical Trials Register DRKS00017606; https://tinyurl.com/27c9kmwy.

Project description:ImportanceGamification, the application of game design elements such as points and levels in nongame contexts, is often used in digital health interventions, but evidence on its effectiveness is limited.ObjectiveTo test the effectiveness of a gamification intervention designed using insights from behavioral economics to enhance social incentives within families to increase physical activity.Design, setting, and participantsThe Behavioral Economics Framingham Incentive Trial (BE FIT) was a randomized clinical trial with a 12-week intervention period and a 12-week follow-up period. The investigation was a community-based study between December 7, 2015, and August 14, 2016. Participants in the modified intent-to-treat analysis were adults enrolled in the Framingham Heart Study, a long-standing cohort of families.InterventionsAll participants tracked daily step counts using a wearable device or a smartphone, established a baseline, selected a step goal increase, and received daily individual feedback on goal performance by text message or email for 24 weeks. Families in the gamification arm could earn points and progress through levels based on physical activity goal achievement during the 12-week intervention. The game design was meant to enhance collaboration, accountability, and peer support.Main outcomes and measuresThe primary outcome was the proportion of participant-days that step goals were achieved during the intervention period. Secondary outcomes included the proportion of participant-days that step goals were achieved during the follow-up period and the change in the mean daily steps during the intervention and follow-up periods.ResultsAmong 200 adults comprising 94 families, the mean age was 55.4 years, and 56.0% (n = 112) were female. During the intervention period, participants in the gamification arm achieved step goals on a significantly greater proportion of participant-days (0.53 vs 0.32; adjusted difference, 0.27; 95% CI, 0.20-0.33; P < .001) and had a significantly greater increase in the mean daily steps compared with baseline (1661 vs 636; adjusted difference, 953; 95% CI, 505-1401; P < .001) than the control arm. During the follow-up period, physical activity in the gamification arm declined but remained significantly greater than that in the control arm for the proportion of participant-days achieving step goals (0.44 vs 0.33; adjusted difference, 0.12; 95% CI, 0.05-0.19; P < .001) and the mean daily steps compared with baseline (1385 vs 798; adjusted difference, 494; 95% CI, 170-818; P < .01).Conclusions and relevanceGamification designed to leverage insights from behavioral economics to enhance social incentives significantly increased physical activity among families in the community.Trial registrationclinicaltrials.gov Identifier: NCT02531763.

Project description:BackgroundWomen with obesity and infertility are counseled to lose weight prior to conception and infertility treatment to improve pregnancy rates and birth outcomes, although confirmatory evidence from randomized trials is lacking. We assessed whether a preconception intensive lifestyle intervention with acute weight loss is superior to a weight neutral intervention at achieving a healthy live birth.Methods and findingsIn this open-label, randomized controlled study (FIT-PLESE), 379 women with obesity (BMI ≥ 30 kg/m2) and unexplained infertility were randomly assigned in a 1:1 ratio to 2 preconception lifestyle modification groups lasting 16 weeks, between July 2015 and July 2018 (final follow-up September 2019) followed by infertility therapy. The primary outcome was the healthy live birth (term infant of normal weight without major anomalies) incidence. This was conducted at 9 academic health centers across the United States. The intensive group underwent increased physical activity and weight loss (target 7%) through meal replacements and medication (Orlistat) compared to a standard group with increased physical activity alone without weight loss. This was followed by standardized empiric infertility treatment consisting of 3 cycles of ovarian stimulation/intrauterine insemination. Outcomes of any resulting pregnancy were tracked. Among 191 women randomized to standard lifestyle group, 40 dropped out of the study before conception; among 188 women randomized to intensive lifestyle group, 31 dropped out of the study before conception. All the randomized women were included in the intent-to-treat analysis for primary outcome of a healthy live birth. There were no significant differences in the incidence of healthy live births [standard 29/191(15.2%), intensive 23/188(12.2%), rate ratio 0.81 (0.48 to 1.34), P = 0.40]. Intensive had significant weight loss compared to standard (-6.6 ± 5.4% versus -0.3 ± 3.2%, P < 0.001). There were improvements in metabolic health, including a marked decrease in incidence of the metabolic syndrome (baseline to 16 weeks: standard: 53.6% to 49.4%, intensive 52.8% to 32.2%, P = 0.003). Gastrointestinal side effects were significantly more common in intensive. There was a higher, but nonsignificant, first trimester pregnancy loss in the intensive group (33.3% versus 23.7% in standard, 95% rate ratio 1.40, 95% confidence interval [CI]: 0.79 to 2.50). The main limitations of the study are the limited power of the study to detect rare complications and the design difficulty in finding an adequate time matched control intervention, as the standard exercise intervention may have potentially been helpful or harmful.ConclusionsA preconception intensive lifestyle intervention for weight loss did not improve fertility or birth outcomes compared to an exercise intervention without targeted weight loss. Improvement in metabolic health may not translate into improved female fecundity.Trial registrationClinicalTrials.gov NCT02432209.

Project description:Background:Adherence to nutritional guidelines for chronic disease prevention and management remains a challenge in clinical practice. Innovative strategies are needed to help optimise dietary behaviour change. Objective:The objective of this study was to determine if a nutrigenomics-guided lifestyle intervention programme could be used to motivate greater dietary adherence and change in dietary intake short-term, moderate-term and long-term compared to the gold-standard population-based weight management intervention (Group Lifestyle Balance (GLB)/Diabetes Prevention Programme (DPP)). Design:The Nutrigenomics, Overweight/Obesity, and Weight Management (NOW) randomised controlled trial is a pragmatic, parallel-group, superiority clinical trial (n=140), which was conducted at the East Elgin Family Health Team (EEFHT). GLB weight management groups were prerandomised 1:1 to receive either the standard GLB programme or a modified GLB+nutrigenomics (GLB+NGx) programme. Three 24-hour recalls were collected at baseline, 3, 6 and 12 months using the validated multiple pass method. Research assistants collecting the three 24-hour recalls were blinded to the participants' group assignments. Statistical analyses included split plot analyses of variance (ANOVAs), two-way ANOVAs, binary logistic regression, ?2 and Fisher's exact tests. Using the Theory of Planned Behaviour as guidance, key confounding factors of behaviour change were considered in the analyses. This study was registered with clinicaltrials.gov (NCT03015012). Results:Only the GLB+NGx group significantly reduced their total fat intake from baseline to 12-month follow-up (from 36.0%±4.8%?kcal to 30.2%±8.7%?kcal, p=0.02). Long-term dietary adherence to total fat and saturated fat guidelines was also significantly (p<0.05) greater in the GLB+NGx group compared to the standard GLB group. Conclusions:Weight management interventions guided by nutrigenomics can motivate long-term improvements in dietary fat intake above and beyond gold-standard population-based interventions.

Dataset Information

Filipinos Fit and Trim - A feasible and efficacious DPP-based intervention trial.

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Filipinos Fit and Trim - A feasible and efficacious DPP-based intervention trial.

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