Evaluating the effects of time-restricted eating on overweight and obese women with polycystic ovary syndrome: A randomized controlled trial study protocol.

Time-restricted eating (TRE) manages weight effectively, but choosing how long and what time window remain debatable. Although an 8:00 a.m. to 16:00 p.m. time frame is reported to show positive results in most weight loss trial, its safety and efficacy in overweight and obese women with polycystic ovary syndrome (PCOS) is uncertain. This randomized controlled trial is conducted to evaluate the safety and efficacy of TRE in specific populations. This study aims to assess the 6-month effects of TRE on weight change, metabolic improvement, reproductive recovery, and health-related quality of life in overweight and obese women with polycystic ovary syndrome (PCOS), compared to those who did not receive TRE. This randomized controlled trial will enroll 96 overweight and obese women with polycystic ovary syndrome (PCOS), who will be randomly assigned to either a TRE group (with an eating window from 8:00 a.m. to 16:00 p.m.) or a control group (without eating time restrictions), with 49 participants in each group. Evaluators and data analysts will remain blinded to group allocation throughout the study. The primary outcomes, including changes in weight and body mass index (BMI), will be assessed weekly. Secondary outcomes, encompassing alterations in sex hormones, metabolic parameters, body composition, sleep quality, quality of life, anxiety, and depression, will be evaluated monthly. Compliance and safety will be continuously monitored throughout the study. Additionally, a 6-month follow-up will be conducted at the end of the trial to assess the long-term effects of TRE. Statistical analysis will include the Anderson-Darling test for normality, T-test/Wilcoxon test based on distribution, mixed-effects models for assessing time/group effects, Cox model for time-to-event analysis, repeated ANOVA for change analysis, and sensitivity analysis. All tests will be conducted using appropriate software, with a significance level set at P<0.05. Missing data will be imputed. The purpose of this study protocol is to further evaluate the effects of TRE in overweight and obese women with PCOS through a randomized controlled trial (RCT). Findings from this study are expected to provide new dietary intervention strategies for overweight and obese PCOS participants. This study has received ethics approval from the Medical Ethics Committee of the University of South China (Number: NHHL027). Participants are included after signing informed consent. Results will be submitted for publication in peer-reviewed journals. Trail registration number: ChiCTR2400086815.

Liu H ，Shangguan F ，Liu F ，Guo Y ，Yu H ，Li H ，Su Y ，Li Z ... -  《PLoS One》

Defining the optimum strategy for identifying adults and children with coeliac disease: systematic review and economic modelling.

Elwenspoek MM ，Thom H ，Sheppard AL ，Keeney E ，O'Donnell R ，Jackson J ，Roadevin C ，Dawson S ，Lane D ，Stubbs J ，Everitt H ，Watson JC ，Hay AD ，Gillett P ，Robins G ，Jones HE ，Mallett S ，Whiting PF ... -  《-》

Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity.

Obesity is considered to be a risk factor for various diseases, and its incidence has tripled worldwide since 1975. In addition to potentially being at risk for adverse health outcomes, people with overweight or obesity are often stigmatised. Behaviour change interventions are increasingly delivered as mobile health (m-health) interventions, using smartphone apps and wearables. They are believed to support healthy behaviours at the individual level in a low-threshold manner. To assess the effects of integrated smartphone applications for adolescents and adults with overweight or obesity. We searched CENTRAL, MEDLINE, PsycINFO, CINAHL, and LILACS, as well as the trials registers ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform on 2 October 2023 (date of last search for all databases). We placed no restrictions on the language of publication. Participants were adolescents and adults with overweight or obesity. Eligible interventions were integrated smartphone apps using at least two behaviour change techniques. The intervention could target physical activity, cardiorespiratory fitness, weight loss, healthy diet, or self-efficacy. Comparators included no or minimal intervention (NMI), a different smartphone app, personal coaching, or usual care. Eligible studies were randomised controlled trials of any duration with a follow-up of at least three months. We used standard Cochrane methodology and the RoB 2 tool. Important outcomes were physical activity, body mass index (BMI) and weight, health-related quality of life, self-efficacy, well-being, change in dietary behaviour, and adverse events. We focused on presenting studies with medium- (6 to < 12 months) and long-term (≥ 12 months) outcomes in our summary of findings table, following recommendations in the core outcome set for behavioural weight management interventions. We included 18 studies with 2703 participants. Interventions lasted from 2 to 24 months. The mean BMI in adults ranged from 27 to 50, and the median BMI z-score in adolescents ranged from 2.2 to 2.5. Smartphone app versus no or minimal intervention Thirteen studies compared a smartphone app versus NMI in adults; no studies were available for adolescents. The comparator comprised minimal health advice, handouts, food diaries, smartphone apps unrelated to weight loss, and waiting list. Measures of physical activity: at 12 months' follow-up, a smartphone app compared to NMI probably reduces moderate to vigorous physical activity (MVPA) slightly (mean difference (MD) -28.9 min/week (95% confidence interval (CI) -85.9 to 28; 1 study, 650 participants; moderate-certainty evidence)). We are very uncertain about the results of estimated energy expenditure and cardiorespiratory fitness at eight months' follow-up. A smartphone app compared with NMI probably results in little to no difference in changes in total activity time at 12 months' follow-up and leisure time physical activity at 24 months' follow-up. Anthropometric measures: a smartphone app compared with NMI may reduce BMI (MD of BMI change -2.6 kg/m2, 95% CI -6 to 0.8; 2 studies, 146 participants; very low-certainty evidence) at six to eight months' follow-up, but the evidence is very uncertain. At 12 months' follow-up, a smartphone app probably resulted in little to no difference in BMI change (MD -0.1 kg/m2, 95% CI -0.4 to 0.3; 1 study; 650 participants; moderate-certainty evidence). A smartphone app compared with NMI may result in little to no difference in body weight change (MD -2.5 kg, 95% CI -6.8 to 1.7; 3 studies, 1044 participants; low-certainty evidence) at 12 months' follow-up. At 24 months' follow-up, a smartphone app probably resulted in little to no difference in body weight change (MD 0.7 kg, 95% CI -1.2 to 2.6; 1 study, 245 participants; moderate-certainty evidence). A smartphone app compared with NMI may result in little to no difference in self-efficacy for a physical activity score at eight months' follow-up, but the results are very uncertain. A smartphone app probably results in little to no difference in quality of life and well-being at 12 months (moderate-certainty evidence) and in little to no difference in various measures used to inform dietary behaviour at 12 and 24 months' follow-up. We are very uncertain about adverse events, which were only reported narratively in two studies (very low-certainty evidence). Smartphone app versus another smartphone app Two studies compared different versions of the same app in adults, showing no or minimal differences in outcomes. One study in adults compared two different apps (calorie counting versus ketogenic diet) and suggested a slight reduction in body weight at six months in favour of the ketogenic diet app. No studies were available for adolescents. Smartphone app versus personal coaching Only one study compared a smartphone app with personal coaching in adults, presenting data at three months. Two studies compared these interventions in adolescents. A smartphone app resulted in little to no difference in BMI z-score compared to personal coaching at six months' follow-up (MD 0, 95% CI -0.2 to 0.2; 1 study; 107 participants). Smartphone app versus usual care Only one study compared an app with usual care in adults but only reported data at three months on participant satisfaction. No studies were available for adolescents. We identified 34 ongoing studies. The available evidence is limited and does not demonstrate a clear benefit of smartphone applications as interventions for adolescents or adults with overweight or obesity. While the number of studies is growing, the evidence remains incomplete due to the high variability of the apps' features, content and components, which complicates direct comparisons and assessment of their effectiveness. Comparisons with either no or minimal intervention or personal coaching show minor effects, which are mostly not clinically significant. Minimal data for adolescents also warrants further research. Evidence is also scarce for low- and middle-income countries as well as for people with different socio-economic and cultural backgrounds. The 34 ongoing studies suggest sustained interest in the topic, with new evidence expected to emerge within the next two years. In practice, clinicians and healthcare practitioners should carefully consider the potential benefits, limitations, and evolving research when recommending smartphone apps to adolescents and adults with overweight or obesity.

Metzendorf MI ，Wieland LS ，Richter B 《Cochrane Database of Systematic Reviews》

The impact of a lifestyle promotion program on anthropometric and clinical manifestations in adolescents with polycystic ovarian syndrome: a randomized controlled trial.

Lifestyle modification can have beneficial effects on improving symptoms of ovary syndrome and anthropometric changes, particularly in obese individuals… However, it is not clear whether these affects in obese adolescents with PCOS are the same as non-PCOS adolescents. We had a study question" Can lifestyle promotion programs, which focus on changing behavioral habits, have an effect on anthropometric parameters and the manifestation of polycystic ovary syndrome (PCOS) in adolescents?" This was a cluster randomized trial (CRT) that started from January 2021 and follow-up ended in March 2022. 128 participants included adolescent girls (from 14 to 18 years old). The status of PCOS was determined for the participants, following which both the PCOS-afflicted and non-PCOS cohorts were subjected to randomization to either partake in a lifestyle promotion program or to proceed without it. This program included eight sessions that were designed to be implemented for two months. This intervention provides recommendations for a balanced diet and regular exercise, as well as advice on behavior change for adolescents, including those with PCOS, regardless of their weight. All participants were followed up for 12 months and were evaluated at three time points: baseline, 6 and 12 months. Outcomes included changes in the anthropometric indices (weight, hip and waist circumstance), regularity of menstrual cycle, hirsutism score by the modified-Ferriman-Gallwey scale, acne score by the Investigator's Global Assessment Scale, hair loss scores by the Sinclair Graphic Instrument and then physical activity by the Caspian tool and dietary intake status by the Food Frequency Questionnaire. Data was analyzed using the non-parametric Mann-Whitney test for variables with two-time point assessments and generalized estimation equations (GEE) for variables with three time point assessments. In the study, the intervention group of girls with PCOS exhibited a significant reduction in weight and waist circumference, with an average decrease of 3.14 kg and 4.68 cm, respectively (P < 0.001), compared to the PCOS control group. Similarly, the non-PCOS intervention group showed a decrease in these factors by 2.60 kg and 4.95 cm (P < 0.001) when compared to the non-PCOS control group. After 12 months of intervention, the odds ratio (OR) for menstrual regularity in the PCOS intervention group increased to 3.30 (95% CI: 2.06, 5.25), and the acne score significantly decreased with an OR of 0.46 (95% CI: 0.31, 0.70). In contrast, the non-PCOS intervention group experienced an increase in the OR for menstrual regularity to 2.45 (95% CI: 1.33, 4.25) and an improved in acne score with an OR of 0.44 (95% CI: 0.28, 0.69). No notable differences were observed in the nutritional status among all groups post-intervention. However, a significant increase in physical activity levels, measured in metabolic equivalent minutes per week (met/min/week), was recorded in both intervention groups (p < 0.05). Manifestations of PCOS in adolescents are improved by a lifestyle promotion program and high schools are considered an appropriate setting to identify those with PCOS and the implementation of a lifestyle modification program. This program was also shown to promote healthy lifestyles for non-PCOS adolescents. Trial registration number: irct.ir number: IRCT20200114046123N1.

Nahidi F ，Ramezani Tehrani F ，Ghodsi D ，Jafari M ，Majd HA ，Abdolahian S ... -  《BMC Womens Health》

Exploring the effects of time-restricted eating on body weight and associated cardiometabolic outcomes in South African women living with HIV (TESSA): protocol for a randomised controlled trial.

We codesigned an intervention with a low-resourced community with the aim to investigate the effects of time-restricted eating (TRE) on changes in body weight and associated cardiometabolic outcomes in South African women living with overweight/obesity and HIV who have initiated dolutegravir (DTG)-based antiretroviral therapy (ART). Women with overweight or obesity (body mass index ≥25 kg/m², no upper limit), aged 20-45 years, living with HIV and in a low-resourced community, and receiving DTG-based ART for less than 2 years will be recruited from a community healthcare centre in Khayelitsha, Cape Town (n=152). Participants will be randomised 1:1 to the TRE group (n=76) or standard of care control group (n=76) for 12 months. The TRE group will be required to restrict their eating window to ~8-10 hours/day and will receive nutritional information sessions at baseline and at 3, 6, 9 and 12 months. The primary outcome of body weight will be assessed at baseline and monthly. Cardiometabolic measures will be reported as secondary outcomes. At baseline, 6- and 12 months, an oral glucose tolerance test (to estimate insulin sensitivity and beta-cell function), questionnaires (sociodemographic, food insecurity, quality of life, social support and sleep quality) and a quantified food frequency questionnaire (total energy and macronutrient composition) will be completed. Every 3 months, appetite ratings, bioelectrical impedance (fat mass and fat-free mass), fasting venous bloods (glucose, insulin, gut hormones and systemic inflammation) and process evaluation (qualitative interviews) will be completed. Monthly monitoring will also include anthropometry and blood pressure. The study is conducted in accordance with the Declaration of Helsinki and has been approved by the Human Research Ethics Committee of the University of Cape Town (628/2021). Verbal and written consent is required from study participants. Results of this study will be published in peer-reviewed journals and presented at conferences. PACTR202302484999720.

Mendham AE ，Goedecke JH ，Heckens L ，Hoosen F ，Pico ML ，Kengne AP ，Christensen DL ，Olesen OF ，Quist JS ，Dave J ，Færch K ，Groth Grunnet L ... -  《-》