Sustained effects of a brief and standardised acupuncture approach on menopausal symptoms: post hoc analysis of the ACOM randomised controlled trial

2020 ◽  
Vol 38 (6) ◽  
pp. 396-406
Author(s):  
Kamma Sundgaard Lund ◽  
Volkert Siersma ◽  
Christine Winther Bang ◽  
John Brodersen ◽  
Frans Boch Waldorff
Keyword(s):  
Treatment Effect ◽  
Acupuncture Treatment ◽  
Controlled Trial ◽  
Intervention Group ◽  
Post Treatment ◽  
Menopausal Symptoms ◽  
Scale Scores ◽  
Pre Treatment ◽  
Randomised Controlled

Background Our objective was to investigate whether the effect of a brief and standardised acupuncture approach persists after the end of the acupuncture treatment (post-treatment effect) and whether the anticipation of future acupuncture treatment affects menopausal symptoms (pre-treatment effect). Method This study is a post hoc analysis of data from a randomised controlled trial where women with moderate to severe menopausal symptoms were offered weekly acupuncture treatment over five consecutive weeks and randomised (1:1) to an early intervention group that received treatment immediately and a late intervention group with a 6-week delay. The acupuncture style was Western medical, administered at CV3, CV4 and bilateral LR8, SP6 and SP9. Acupuncturists were general practitioners. The effect was evaluated repeatedly during and after the interventions using scales from the validated MenoScores Questionnaire (MSQ) for hot flushes (HF), day and night sweats (DNS), general sweating (GS) and menopausal-specific sleeping problems (MSSP) with a 26-week follow-up period (corresponding to 21 or 15 weeks post-treatment for the early and late intervention groups, respectively). Multivariable linear mixed models were used to analyse the extent and duration of effects. Results Seventy participants were included in the study. Four participants dropped out. Furthermore, one participant was excluded from the short- and long-term follow-up analyses after the insertion of a hormonal intrauterine device, and nine participants were excluded from the long-term follow-up analysis due to the initiation of co-interventions. For each of the four outcomes, the effect was sustained up to 21 weeks post-treatment with an effect size that was only slightly diminished. A small, but significant, pre-treatment effect was observed in the HF scale scores. The same trend, although not significant, was observed in the DNS and MSSP scale scores. No serious harms were reported. Conclusion This study demonstrated that the overall effect of a brief and standardised acupuncture treatment on menopause-relevant outcomes was sustained up to 21 weeks post-treatment and that there was a small pre-treatment effect.

A Comparison of Acupuncture with Advice and Exercises on the Symptomatic Treatment of Osteoarthritis of the Hip – a Randomised Controlled Trial

2001 ◽  
Vol 19 (1) ◽  
pp. 19-26 ◽  
Author(s):  
Roisin Haslam
Keyword(s):  
Controlled Trial ◽  
Randomised Trial ◽  
Symptomatic Treatment ◽  
Post Treatment ◽  
Control Group ◽  
Group A ◽  
Pre Treatment ◽  
Group B ◽  
Randomised Controlled

Acupuncture is becoming a common technique within the physiotherapy profession as a treatment modality for pain relief; however, few randomised controlled trials have been undertaken to assess the effectiveness of acupuncture, particularly in the treatment of osteoarthritis (OA) of the hip. Therefore, a randomised trial to compare the effectiveness of acupuncture with advice and exercises on the symptomatic treatment of OA of the hip was carried out. Thirty-two patients awaiting a total hip arthroplasty were randomly allocated to either the experimental group, (A), to have six sessions of acupuncture each lasting up to 25 minutes, or the control group, (B), to be given advice and exercises for their hip over a six week period. Group A consisted of three men and 13 women, and group B consisted of four men and eight women. The average age in group A was 66 years and in group B it was 68 years. Patients were assessed for pain and functional ability, using a modified version of the WOMAC questionnaire, pre-treatment, immediately post-treatment and at eight weeks post-treatment. The pre-treatment WOMAC scores in the two groups were similar (p=0.85). There was a significant improvement in group A (decrease in WOMAC score) immediately post-treatment (p=0.002) and this was maintained at the eight-week follow-up (p=0.03). There were no significant changes in group B. When the changes in WOMAC scores were compared between groups, a significantly greater improvement was found between pre-treatment and immediately post-treatment in group A, compared with group B (p=0.02). The changes between pre-treatment and the eight-week follow-up also showed a significant improvement in group A compared with group B (p=0.03). In conclusion, this trial supports the hypothesis that acupuncture is more effective than advice and exercises in the symptomatic treatment of OA of the hip.

scholarly journals Increasing the uptake of long-acting reversible contraception in general practice: the Australian Contraceptive ChOice pRoject (ACCORd) cluster randomised controlled trial longitudinal follow-up protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e035895
Author(s):  
Danielle Mazza ◽  
Natalie Amos ◽  
Cathy J Watson ◽  
Kevin McGeechan ◽  
Marion Haas ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
Accord Study ◽  
Contraceptive Choice ◽  
Long Acting ◽  
Randomised Controlled

IntroductionThrough addressing main barriers to the uptake of long-acting reversible contraceptives (LARCs) among Australian women, the Australian Contraceptive ChOice pRoject (ACCORd) trialled an educational intervention targeting general practitioners (GPs) and provided those in the intervention group with a rapid referral service for quick insertion. The cluster randomised controlled trial resulted in greater uptake of LARC in the intervention group. This protocol paper describes a longitudinal follow-up to the ACCORd Study to assess the long-term efficacy and cost-effectiveness of the intervention.Methods and analysisWomen participants (patients of ACCORd GPs) completed a baseline, 6-month and 12-month survey. These participants will be invited to complete an additional follow-up survey 3 years post completion of their baseline interview. Based on the original ACCORd Study tools, the online survey will address long-term outcomes including contraceptive continuation rates and reproductive history, any unintended pregnancies, satisfaction and concerns with their current contraceptive method, and an assessment of quality of life. We will analyse data using binary regression models with generalised estimating equations and robust standard errors to account for clustering.DiscussionDemonstration of sustained use, effectiveness at reducing unwanted pregnancies and cost-effectiveness of this strategy among this cohort of Australian primary care patients, will strengthen the policy and programme urgency of addressing wider dissemination of these strategies and replicating the study elsewhere.Ethics and disseminationThe ACCORd Study received approval from the Monash University Human Research Ethics Committee: CF16/188-201000080. Additionally, an amendment to conduct this 3-year longitudinal follow-up survey has been approved. The trial follow-up outcomes will be disseminated through formal academic pathways, including journal articles, national and international conferences and reports as well as using more ‘mainstream’ strategies such as seminars, workshops and media engagement. Additionally, outcomes will be communicated through policy briefs to Australian state and federal governments.Trail registration numberThis trial is registered with the Australian and New Zealand Trials Registry ACTRN12615001346561. Recruitment and data collection have been completed for the baseline, 6-month and 12-month surveys. Data collection for the 3-year survey commenced in August 2019.

scholarly journals Effectiveness of one-to-one peer support for patients with severe mental illness – a randomised controlled trial

2017 ◽  
Vol 42 ◽  
pp. 103-110 ◽  
Author(s):  
C.I. Mahlke ◽  
S. Priebe ◽  
K. Heumann ◽  
A. Daubmann ◽  
K. Wegscheider ◽  
...  
Keyword(s):  
Mental Illness ◽  
Peer Support ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Treatment As Usual ◽  
Secondary Outcomes ◽  
One To One ◽  
Randomised Controlled

AbstractBackgroundOne-to-one peer support is a resource-oriented approach for patients with severe mental illness. Existing trials provided inconsistent results and commonly have methodological shortcomings, such as poor training and role definition of peer supporters, small sample sizes, and lack of blinded outcome assessments.MethodsThis is a randomised controlled trial comparing one-to-one peer support with treatment as usual. Eligible were patients with severe mental illnesses: psychosis, major depression, bipolar disorder or borderline personality disorder of more than two years’ duration. A total of 216 patients were recruited through in- and out-patient services from four hospitals in Hamburg, Germany, with 114 allocated to the intervention group and 102 to the control group. The intervention was one-to-one peer support, delivered by trained peers and according to a defined role specification, in addition to treatment as usual over the course of six months, as compared to treatment as usual alone. Primary outcome was self-efficacy measured on the General Self-Efficacy Scale at six-month follow-up. Secondary outcomes included quality of life, social functioning, and hospitalisations.ResultsPatients in the intervention group had significantly higher scores of self-efficacy at the six-month follow-up. There were no statistically significant differences on secondary outcomes in the intention to treat analyses.ConclusionsThe findings suggest that one-to-one peer support delivered by trained peer supporters can improve self-efficacy of patients with severe mental disorders over a one-year period. One-to-one peer support may be regarded as an effective intervention. Future research should explore the impact of improved self-efficacy on clinical and social outcomes.

scholarly journals An intervention to optimise coach-created motivational climates and reduce athlete willingness to dope (CoachMADE): a three-country cluster randomised controlled trial

2020 ◽  
pp. bjsports-2019-101963
Author(s):  
Nikos Ntoumanis ◽  
Eleanor Quested ◽  
Laurie Patterson ◽  
Stella Kaffe ◽  
Susan H Backhouse ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Trial Registration ◽  
Perceived Effectiveness ◽  
Cluster Randomised ◽  
Randomised Controlled

ObjectivesCoach-centred antidoping education is scarce. We tested the efficacy of a motivationally informed antidoping intervention for coaches, with their athletes’ willingness to dope as the primary outcome.MethodsWe delivered a cluster randomised controlled trial in Australia, the UK and Greece. This study was a parallel group, two-condition, superiority trial. Participants were 130 coaches and 919 athletes. Coaches in the intervention group attended two workshops and received supplementary information to support them in adopting a motivationally supportive communication style when discussing doping-related issues with their athletes. Coaches in the control condition attended a standard antidoping workshop that provided up-to-date information on antidoping issues yet excluded any motivation-related content. Assessments of willingness to dope (primary outcome) and other secondary outcomes were taken at baseline, postintervention (3 months) and at a 2-month follow up.ResultsCompared with athletes in the control group, athletes in the intervention group reported greater reductions in willingness to take prohibited substances (effect size g=0.17) and psychological need frustration (g=0.23) at postintervention, and greater increases in antidoping knowledge (g=0.27) at follow-up. Coaches in the intervention group reported at postintervention greater increases in efficacy to create an antidoping culture (g=0.40) and in perceived effectiveness of need supporting behaviours (g=0.45) to deal with doping-related situations. They also reported greater decreases in doping attitudes (g=0.24) and perceived effectiveness of need thwarting behaviours (g=0.35).ConclusionsAntidoping education programmes should consider incorporating principles of motivation, as these could be beneficial to coaches and their athletes. We offer suggestions to strengthen these programmes, as most of the effects we observed were not sustained at follow-up.Trial registration numberThis trial has been registered with the Australian New Zealand Clinical Trials Registry (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371465&isReview=true).

Personalized attention control therapy for PTSD: effectiveness and moderators of outcome in a randomized controlled trial

2020 ◽  
pp. 1-11
Author(s):  
Adva Segal ◽  
Daniel S. Pine ◽  
Yair Bar-Haim
Keyword(s):  
Treatment Outcome ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Post Treatment ◽  
Attention Control ◽  
Randomized Controlled ◽  
Control Therapy ◽  
Pre Treatment ◽  
Attentional Interference

Abstract Background Previous randomized controlled trials (RCTs) suggest that attention control therapy (ACT), targeting aberrant fluctuations of attention toward and away from threats in patients with PTSD, may be effective in reducing symptoms. The current RCT examined whether the use of personalized-trauma stimuli enhances ACT efficacy in patients with PTSD. Additional moderators of treatment outcome were tested on an exploratory basis. Methods Sixty patients with PTSD were randomly assigned to either personalized ACT, non-personalized ACT, or a control condition. Changes in symptoms were examined across pre-treatment, post-treatment, and a 3-month follow-up. Attentional interference was examined pre- and post-treatment. Baseline clinical and cognitive indices as well as the time elapsed since the trauma were tested as potential moderators of treatment outcome. Results A significant reduction in clinical symptoms was noted for all three conditions with no between-group differences. Attention bias variability decreased following ACT treatment. Personalized ACT was more effective relative to the control condition when less time had elapsed since the trauma. Baseline clinical and cognitive indices did not moderate treatment outcome. Conclusions In this RCT of patients with PTSD, ACT was no more effective in reducing PTSD symptoms than a control condition. The data also suggest a potential benefit of personalized ACT for patients who experienced their trauma more recently.

scholarly journals Decision aid on disclosure of mental health status to an employer: feasibility and outcomes of a randomised controlled trial

2013 ◽  
Vol 203 (5) ◽  
pp. 350-357 ◽  
Author(s):  
Claire Henderson ◽  
Elaine Brohan ◽  
Sarah Clement ◽  
Paul Williams ◽  
Francesca Lassman ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Decision Aid ◽  
Controlled Trial ◽  
Intervention Group ◽  
Decisional Conflict ◽  
Full Time ◽  
Randomised Controlled

BackgroundMany mental health service users delay or avoid disclosing their condition to employers because of experience, or anticipation, of discrimination. However, non-disclosure precludes the ability to request ‘reasonable adjustments’. There have been no intervention studies to support decisionmaking about disclosure to an employer.AimsTo determine whether the decision aid has an effect that is sustained beyond its immediate impact; to determine whether a large-scale trial is feasible; and to optimise the designs of a larger trial and of the decision aid.MethodIn this exploratory randomised controlled trial (RCT) in London, participants were randomly assigned to use of a decision aid plus usual care or usual care alone. Follow-up was at 3 months. Primary outcomes were: (a) stage of decision-making; (b) decisional conflict; and (c) employment-related outcomes (trial registration number: NCT01379014).ResultsWe recruited 80 participants and interventions were completed for 36 out of 40 in the intervention group; in total 71 participants were followed up. Intention-to-treat analysis showed that reduction in decisional conflict was significantly greater in the intervention group than among controls (mean improvement −22.7 (s.d. = 15.2) v. −11.2 (s.d. = 18.1), P = 0.005). More of the intervention group than controls were in full-time employment at follow-up (P = 0.03).ConclusionsThe observed reduction in decisional conflict regarding disclosure has a number of potential benefits which next need to be tested in a definitive trial.

scholarly journals Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

2020 ◽  
Author(s):  
Ricard Carrillo Muñoz ◽  
Jose Luis Ballve Moreno ◽  
Ivan Villar Balboa ◽  
Yolanda Rando Matos ◽  
Oriol Cunillera Puertolas ◽  
...  
Keyword(s):  
Primary Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Perceived Disability ◽  
Randomised Controlled ◽  
The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

scholarly journals Testing the Efficacy of ‘Unlearning’, a Mindfulness and Compassion-Based Programme for Cultivating Nonviolence in Teenagers: A Randomised Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Irene Delgado-Suárez ◽  
Yolanda López-del-Hoyo ◽  
Javier García-Campayo ◽  
Adrián Pérez-Aranda ◽  
Marta Modrego-Alarcón ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Multiple Comparisons ◽  
Post Treatment ◽  
Control Group ◽  
Self Compassion ◽  
Baseline Levels ◽  
Secondary Outcomes ◽  
Randomised Controlled

Background: Most programmes developed to reduce aggressive attitudes among teenagers are based on cultivating nonviolence, a construct that has been related to compassion and, more indirectly, mindfulness. This study aims at testing the efficacy of ‘Unlearning’, a mindfulness and compassion-based programme, for reducing aggressive attitudes in adolescents.Method: A sample of 164 students from three high schools in Zaragoza (Spain) participated in the study. They were randomly assigned to (1) ‘Unlearning’, or (2) relaxation programme. Three assessment points were established: baseline, post-treatment and a 4-month follow-up. The outcome variables were the subscales of the ‘Attitudes Toward Social Aggression Scale’. Mindfulness and compassion were assessed as secondary outcomes.Results: ‘Unlearning’ did not produce changes in the primary outcomes, but significant effects were observed post-treatment in self-compassion; and in the follow-up, in self-compassion and mindfulness. The control group did not experience any change post-treatment, but a significant effect in mindfulness was observed in the follow-up. The intergroup analyses indicated that ‘Unlearning’ improved self-compassion, both post-treatment (t = −2.48, p = 0.014) and after 4-months (t = −2.03, p = 0.044), although these results were not statistically significant after correcting for multiple comparisons.Conclusion: ‘Unlearning’ did not produce significant reductions in aggressive attitudes compared to the control group. The low baseline levels may have hindered the efficacy of the interventions. ‘Unlearning’ showed potential to improve self-compassion, which is related to nonviolence, and this may have positive implications for the adolescents. Future interventions should include teachers and families to enhance the effectiveness of the programmes.

scholarly journals An Interactive Sexual Health Literacy Programme for Safe Sex Practice in Female Chinese University Students: A Multicentre, Randomised Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Janet Yuen-Ha Wong ◽  
Wen Zhang ◽  
Yongda Wu ◽  
Edmond Pui Hang Choi ◽  
Herman Hay Ming Lo ◽  
...  
Keyword(s):  
Health Literacy ◽  
Sexual Health ◽  
University Students ◽  
Condom Use ◽  
Sexual Coercion ◽  
Controlled Trial ◽  
Intervention Group ◽  
Literacy Programme ◽  
Randomised Controlled

BACKGROUND Sexual health is a major concern among young adults worldwide, which helps prevent sexually transmitted infectious. To foster individual sexual health, the sexual health literacy should be enhanced. Seldom previous evidence designed to incorporate gender-power dynamics, such as sexual coercion, although the prevalence of sexual coercion stays high in China. OBJECTIVE We aimed to describe the development and systematic evaluation of a sexual health literacy intervention called “Smart Girlfriend” in female Chinese University Students. METHODS A multicentre randomised controlled trial was conducted with 781 female university students at five universities with dormitories in Hong Kong. Inclusion criteria were used to select unmarried female university Chinese students who were ≥18 years old and had not received any sexual health intervention in the past 12 months. The primary outcome was self-reported consistency of condom use with every partner in 3-month assessments at 3-month and 6-month follow-up, analysed using zero/one inflated beta (ZOIB) regression. Knowledge, attitudes, norms, and self-efficacy of condom use were appraised by the 25-item Multidimensional Condom Attitudes Scale (MCAS) as the secondary outcome. Intention to treat was applied in analyses. RESULTS Of 1503 individuals screened, 781 (52%) were randomised into two groups. Retention rates at 3-month and 6-month follow-up were 92% and 91%, respectively. Most participants were born locally (72%), and 18% self-reported a sexual minority orientation. ZOIB results regarding consistency of condom use were not significant (Model 1: OR: 2·25, 95% CrI: [0·84, 6·36]; Model 2: OR: 8·03, 95% CrI: [0·22, 330·31]; Model 3: OR: 1·21, 95% CrI [0·78, 1·86]). Consistency in the intervention group was 5% higher (95% CI: [−1·90, 11·63]) compared with the control group at 3-month follow-up, and 1% higher (95% CI: [−5·81, 8·02]) at 6-month follow-up. MCAS scores at 3-month follow-up (intervention: 122·51 ± 15·97 vs control: 119·86 ± 15·85, p < 0·05) were significantly higher in the intervention group. CONCLUSIONS An interactive computer-based sexual health literacy programme did not significantly increase consistency of condom use compared with one page of condom use information, but temporarily improved knowledge, attitudes, norms, and self-efficacy regarding condom use. CLINICALTRIAL This trial was registered with ClinicalTrials.gov, NCT03695679.

scholarly journals Body mass index and physical activity in seven-year-old children whose mothers exercised during pregnancy: follow-up of a multicentre randomised controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Karen Alterhaug Bjøntegaard ◽  
Signe Nilssen Stafne ◽  
Siv Mørkved ◽  
Kjell Åsmund Salvesen ◽  
Kari Anne I. Evensen
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
University Hospital ◽  
Moderate Intensity ◽  
Control Group ◽  
Exercise Protocol ◽  
Moderate Intensity Exercise ◽  
Randomised Controlled ◽  
Exercise During Pregnancy

Abstract Background There are limited data on long-term outcomes of children whose mothers have followed exercise interventions during pregnancy. The aim of this paper was to investigate whether regular moderate intensity exercise during pregnancy affected the children’s body mass index (BMI) and physical activity (PA) at 7 years of age, and determine the relationship between children’s and mothers’ BMI and PA. Methods This was a follow-up of a multicentre randomised controlled trial, carried out at St. Olavs Hospital, Trondheim University Hospital, and Stavanger University Hospital, Norway (2007–2009 and 2014–2016). Women were randomised to follow a 12-week structured exercise protocol or standard antenatal care during pregnancy. At the 7-year follow-up, parents reported their child’s height, weight, and PA. The mothers also reported their own weight and PA. Main outcome variables were BMI, frequency and duration of moderate to vigorous PA (MVPA), and intensity of PA. Results A total of 855 women were randomised to exercise (n = 429) or standard antenatal care (n = 426) during pregnancy. At follow-up, 164 (38.2%) children and mothers in the intervention group and 117 (27.5%) in the control group participated. We found no group differences in the children’s iso-BMI or PA. Findings were similar when we performed stratified analyses by sex, except boys in the control group spent more time on electrical devices than boys in the intervention group. Subgroup analyses of children of mothers who adhered to the exercise protocol and sensitivity analyses excluding children born preterm, children admitted to the neonatal intensive care unit, and children with diseases or health problems at the 7-year follow-up, did not change the results. Children’s BMI, weekly leisure time MVPA and intensity of PA correlated with mothers’ BMI, daily exercise, and intensity of exercise. Conclusions Regular moderate intensity exercise during pregnancy did not affect BMI or PA of the children at 7 years. Good maternal health should be encouraged as it may influence the health of the next generation. Trial registration The initial RCT study was registered in ClinicalTrials.govNCT00476567.

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