Dataset Information

The 40-Something randomized controlled trial to prevent weight gain in mid-age women.

ABSTRACT:

Background

Obesity prevention is a major public health priority. Despite the health risks associated with weight gain, there has been a distinct lack of research into effective interventions to prevent, rather than treat, obesity particularly at high risk life stages such as menopause in women. This paper describes the rationale for and design of a 2-year randomized controlled trial (RCT) (the 40-Something Study) aimed at testing the feasibility and efficacy of a relatively low intensity intervention designed to achieve weight control in non-obese women about to enter the menopause transition.

Methods and design

The study is a parallel-group RCT consisting of 12 months of intervention (Phase 1) and 12 months of monitoring (Phase 2). Non-obese pre-menopausal healthy females 44-50 years of age were screened, stratified according to Body Mass Index (BMI) category (18.5-24.9 and 25-29.9 kg/m²) and randomly assigned to one of two groups: motivational interviewing (MI) intervention (n = 28), or a self-directed intervention (SDI) (control) (n = 26). The MI intervention consisted of five consultations with health professionals (four with a Dietitian and one with an Exercise Physiologist) who applied components of MI counselling to consultations with the women over a 12 month period. The SDI was developed as a control and these participants received print materials only. Outcome measures were collected at baseline, three, 12, 18 and 24 months and included weight (primary outcome), waist circumference, body composition, blood pressure, plasma markers of metabolic syndrome risk, dietary intake, physical activity and quality of life. Analysis of covariance will be used to investigate outcomes according to intervention type and duration (comparing baseline, 12 and 24 months).

Discussion

The 40-Something study is the first RCT aimed at preventing menopausal weight gain in Australian women. Importantly, this paper describes the methods used to evaluate whether a relatively low intensity, health professional led intervention will achieve better weight control in pre-menopausal women than a self-directed intervention. The results will add to the scant body of literature on obesity prevention methods at an under-researched high-risk life stage, and inform the development of population-based interventions.

Trial registration

ACTRN12611000064909.

SUBMITTER: Williams LT

PROVIDER: S-EPMC4016250 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

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Publications

The 40-Something randomized controlled trial to prevent weight gain in mid-age women.

Williams Lauren T LT Hollis Jenna L JL Collins Clare E CE Morgan Philip J PJ

BMC public health 20131025

<h4>Background</h4>Obesity prevention is a major public health priority. Despite the health risks associated with weight gain, there has been a distinct lack of research into effective interventions to prevent, rather than treat, obesity particularly at high risk life stages such as menopause in women. This paper describes the rationale for and design of a 2-year randomized controlled trial (RCT) (the 40-Something Study) aimed at testing the feasibility and efficacy of a relatively low intensity ...[more]

PMID: 24156558

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Project description:BackgroundWeight gain in perimenopausal women results in increased visceral adipose tissue, leading to metabolic syndrome and associated comorbidities. Despite a high prevalence of weight gain at this life stage, interventions to prevent menopausal obesity are lacking.AimTo test the effectiveness of an intervention delivered by health professionals using a motivational interviewing (MI) counselling style in preventing weight gain in non-obese (body mass index (BMI) 18.5 and 29.9?kg?m(-2)) women in late premenopause.MethodsIn a randomised controlled trial, 54 women (mean (s.d.) age 47.3 (1.8) years; BMI 25.1 (2.4)?kg?m(-2)) who had menstruated within the preceding 3 months were randomly assigned to an MI intervention (n=28) (five health professional MI counselling sessions) or a self-directed intervention (SDI) (print materials only) (n=26). The primary outcome, body weight (kg) and secondary outcomes (blood lipids, glucose, body fat %, lean mass % and waist circumference) were measured at baseline and postintervention (12 months), and intention-to-treat analysis was conducted.ResultsForty women completed all measures and adhered to all protocols. The weight at 12 months for the MI group of 65.6?kg (95% CI: 64.5; 66.8) was significantly different (P=0.034) from the SDI group of 67.4?kg (95% CI: 66.2; 68.6). When stratified by baseline BMI category, the MI group lost significantly more weight (-2.6?kg; 95% CI: -3.9; -1.2) than the SDI group (-0.1?kg; 95% CI: -1.2; 1.0, P=0.002) for the healthy weight women. The overweight women lost weight regardless of the intervention group, with no between-group difference (-3.5?kg; 95% CI: -6.1, -1.0 and -2.3; 95% CI: -4.1, -0.5, P=0.467).ConclusionThis relatively low-intensity intervention, incorporating MI into health professional counselling, not only effectively prevented weight gain but also achieved significant weight loss and decreased diastolic blood pressure. Further refinements are required to optimise outcomes for overweight women.

Project description:BackgroundThe effectiveness of exercise training for preventing excessive gestational weight gain (GWG) and gestational diabetes mellitus (GDM) is still uncertain. As maternal obesity is associated with both GWG and GDM, there is a special need to assess whether prenatal exercise training programs provided to obese women reduce the risk of adverse pregnancy outcomes. Our primary aim was to assess whether regular supervised exercise training in pregnancy could reduce GWG in women with prepregnancy overweight/obesity. Secondary aims were to examine the effects of exercise in pregnancy on 30 outcomes including GDM incidence, blood pressure, blood measurements, skinfold thickness, and body composition.Methods and findingsThis was a single-center study where we randomized (1:1) 91 pregnant women with a prepregnancy body mass index (BMI) ≥ 28 kg/m2 to exercise training (n = 46) or control (standard maternity care) (n = 45). Assessments were done at baseline (pregnancy week 12-18) and in late pregnancy (week 34-37), as well as at delivery. The exercise group was offered thrice weekly supervised sessions of 35 min of moderate intensity endurance exercise and 25 min of strength training. Seventeen women were lost to follow-up (eight in the exercise group and nine in the control group). Our primary endpoint was GWG from baseline testing to delivery. The principal analyses were done as intention-to-treat analyses, with supplementary per protocol analyses where we assessed outcomes in the women who adhered to the exercise program (n = 19) compared to the control group. Mean GWG from baseline to delivery was 10.5 kg in the exercise group and 9.2 kg in the control group, with a mean difference of 0.92 kg (95% CI -1.35, 3.18; p = 0.43). Among the 30 secondary outcomes in late pregnancy, an apparent reduction was recorded in the incidence of GDM (2009 WHO definition) in the exercise group (2 cases; 6.1%) compared to the control group (9 cases; 27.3%), with an odds ratio of 0.1 (95% CI 0.02, 0.95; p = 0.04). Systolic blood pressure was significantly lower in the exercise group (mean 120.4 mm Hg) compared to the control group (mean 128.1 mm Hg), with a mean difference of -7.73 mm Hg (95% CI -13.23, -2.22; p = 0.006). No significant between-group differences were seen in diastolic blood pressure, blood measurements, skinfold thickness, or body composition in late pregnancy. In per protocol analyses, late pregnancy systolic blood pressure was 115.7 (95% CI 110.0, 121.5) mm Hg in the exercise group (significant between-group difference, p = 0.001), and diastolic blood pressure was 75.1 (95% CI 71.6, 78.7) mm Hg (significant between-group difference, p = 0.02). We had planned to recruit 150 women into the trial; hence, under-recruitment represents a major limitation of our results. Another limitation to our study was the low adherence to the exercise program, with only 50% of the women included in the intention-to-treat analysis adhering as described in the study protocol.ConclusionsIn this trial we did not observe a reduction in GWG among overweight/obese women who received a supervised exercise training program during their pregnancy. The incidence of GDM in late pregnancy seemed to be lower in the women randomized to exercise training than in the women receiving standard maternity care only. Systolic blood pressure in late pregnancy was also apparently lower in the exercise group than in the control group. These results indicate that supervised exercise training might be beneficial as a part of standard pregnancy care for overweight/obese women.Trial registrationClinicalTrials.gov NCT01243554.

Project description:Body weight (BW) reduction through energy restriction is ineffective at impacting the obesity epidemic. Shifting from an obesity treatment to weight gain prevention focus may be more effective in decreasing the burden of adult obesity.This was a 1-year randomized controlled trial of weight gain prevention in healthy premenopausal women, aged 18-45 y, with a body mass index (BMI) of >18.5 kg/m(2). Eighty-seven women were randomized to a weight gain prevention intervention delivered by a registered dietitian (RDG) or counselor (CSG), or to a control (CON) group. Eighty-one women (mean ± SD, age: 31.4 ± 8.1 y; BW: 76.1 ± 19.0 kg; BMI: 27.9 ± 6.8 kg/m(2)) completed baseline testing and were included in intention-to-treat analyses; anthropometric, blood pressure, dietary intake and physical activity measurements and biochemical markers of health were measured every three months. Data were analyzed using repeated measures ANCOVA, with significance at P < 0.01.Sixty-two percent of women met the weight gain prevention criteria (BW change within ±3 %) after one year; this did not differ by group assignment. Body fat % was lower in the RDG versus CSG and CON groups at all intervals (P < 0.001). Systolic blood pressure increased from month 6 to 9 and decreased from month 6 to 12 in the CON group (P < 0.001), with a significant group x time interaction (P < 0.01). Estimated carbohydrate intake (%) was higher in the RDG vs. CON group at month 9 (P < 0.01); fat intake (%) was lower in the RDG vs. CON group and CSG vs. CON group at months 3 and 9, respectively (P < 0.01). Estimated fruit intake (svgs/d) was higher in the RDG vs. CON group at months 3, 6, 9 and 12 (P < 0.01), and non-meat protein sources (svgs/d) was higher in the RDG vs. CSG and CON groups at month 3 (P < 0.001). Estimated energy, macronutrient and food group intakes did not change over time.A majority of all participants maintained BW over one year and were able to do so regardless of whether they received nutrition education. Additional studies that include a variety of clinical outcomes are needed to evaluate further aspects of nutrition education on weight gain prevention and health status over the long term.

Project description:ObjectiveTo develop and evaluate the effectiveness of a community behavioural intervention to prevent weight gain and improve health related behaviours in women with young children.DesignCluster randomised controlled trial.SettingA community setting in urban Australia.Participants250 adult women with a mean age of 40.39 years (SD 4.77, range 25-51) and a mean body mass index of 27.82 kg/m(2) (SD 5.42, range 18-47) were recruited as clusters through 12 primary (elementary) schools.InterventionSchools were randomly assigned to the intervention or the control. Mothers whose schools fell in the intervention group (n=127) attended four interactive group sessions that involved simple health messages, behaviour change strategies, and group discussion, and received monthly support using mobile telephone text messages for 12 months. The control group (n=123) attended one non-interactive information session based on population dietary and physical activity guidelines.Main outcome measuresThe main outcome measures were weight change and difference in weight change between the intervention group and the control group at 12 months. Secondary outcomes were changes in serum concentrations of fasting lipids and glucose, and changes in dietary behaviours, physical activity, and self management behaviours.ResultsAll analyses were adjusted for baseline values and the possible clustering effect. Women in the control group gained weight over the 12 month study period (0.83 kg, 95% confidence interval (CI) 0.12 to 1.54), whereas those in the intervention group lost weight (-0.20 kg, -0.90 to 0.49). The difference in weight change between the intervention group and the control group at 12 months was -1.13 kg (-2.03 to -0.24 kg; P<0.05) on the basis of observed values and -1.11 kg (-2.17 to -0.04) after multiple imputation to account for possible bias created by missing values. Secondary analyses after multiple imputation showed a difference in the intervention group compared with the control group for total cholesterol concentration (-0.35 mmol/l, -0.70 to -0.001), self management behaviours (diet score 0.18, 0.13 to 0.33; physical activity score 0.24, 0.05 to 0.43), and confidence to control weight (0.40, 0.11 to 0.69). Regular self weighing was associated with weight loss in the intervention group only (-1.98 kg, -3.75 to -0.23).ConclusionsWeight gain in women with young children could be prevented using a low intensity self management intervention delivered in a community setting. Self management of health behaviours improved with the intervention. The response rate of 12%, although comparable with that in other community studies, might limit the ability to generalise to other populations.Trial registrationAustralian New Zealand Clinical Trials Registry number ACTRN12608000110381.

Project description:Online interventions have emerged as a popular strategy to promote healthy behaviors. Currently, there is little agreement about how to capture online intervention engagement. It is also uncertain who engages with weight-related online interventions and how engagement differs by demographic and weight characteristics.The objectives of this study were to (1) characterize how pregnant women engaged with features of an online intervention to prevent excessive gestational weight gain, (2) identify demographic and weight status subgroups of women within the sample, and (3) examine differences in use of intervention features across the demographic and weight status subgroups.A sample of racially and socioeconomically diverse pregnant women from a northeastern US city was assigned to the intervention group in a randomized controlled trial to prevent excessive gestational weight gain (n=1014). The intervention website included these features: weight-gain tracker, health-related articles, blogs, physical activity and diet goal-setting tools, and local resources. Engagement variables were created to capture the amount, consistency, and patterns of feature use across pregnancy using latent class analysis. Demographic/weight status subgroups were also created using latent class analysis. Differences in engagement across the demographic/weight status subgroups were examined using chi-square analysis.Six engagement patterns emerged: "super-users" (13.02%, 132/1014), "medium-users" (14.00%, 142/1014), "consistent weight-tracker users" (14.99%, 152/1014); "almost consistent weight-tracker users" (21.99%, 223/1014), "inconsistent weight-tracker users" (15.98%, 162/1014), and "non-users" (20.02%, 203/1014). Four demographic/weight status subgroups emerged: three minority and one white. There were different engagement patterns by demographic/weight status subgroups. Super-users were more likely to be in the white subgroup, while non-users were more likely to be in the minority subgroups. However, around a third of women in minority subgroups were consistently or almost consistently engaging with the weight-tracker (black, young women, 32.2%, 67/208; black, heavier women, 37.9%, 50/132; Hispanic women, 27.4%, 32/117).While white and higher income women had higher engagement in general, depending on the measure, there was still considerable engagement by the minority and low-income women.Clinicaltrials.gov: NCT01331564; http://clinicaltrials.gov/ct2/show/NCT01331564 (Archived by WebCite at http://www.webcitation.org/6Rw4yKxI5).

Project description:BackgroundEfforts to manage obesity through weight loss are often unsuccessful as most adults are not able to sustain the major changes in behaviour that are required to maintain weight loss long term. We sought to determine whether small changes in physical activity and diet prevent weight gain in adults with overweight and obesity.MethodsWe randomized 320 sedentary adults with overweight or obesity to monitoring alone (MA, n = 160) or a small change approach (SCA, n = 160). In Phase I (2 yr), MA participants were asked to maintain their normal lifestyle and SCA participants were counselled to make small changes in diet and physical activity, namely a suggested increase in daily step count of 2000 steps with a decrease in energy intake of 100 kcal per day, with group and individual support. Phase II (1 yr) was a passive follow-up period. The difference in change in body weight between groups at 24 and 36 months from baseline was the primary outcome. Additional outcomes included waist circumference and cardiorespiratory fitness.ResultsOverall, 268 participants (83.8%) completed the 2-year intervention, and 239 (74.7%) returned at the end of the follow-up period at 3 years. The difference in body weight change between the SCA and MA groups was significant at 3, 6, 12 and 15 months from baseline, but was no longer significant at 24 months (mean change 0.9 [standard error (SE) 0.5] kg v. -0.4 [SE 0.5] kg; difference -0.6, 95% confidence interval [CI] -1.9 to 0.8) or at 36 months (-1.2 [SE 0.8] v. -0.7 [SE 0.8] kg; difference -0.5, 95% CI -2.2 to 1.2). Changes in waist circumference and cardiorespiratory fitness were not significantly different between groups at 24 or 36 months (both p > 0.1).InterpretationThe SCA did not prevent weight gain compared with monitoring alone at 2 or 3 years in adults with overweight or obesity. On average, we observed prevention of weight gain in both arms of the trial.Trial registrationClinicalTrials.gov, no. NCT02027077.

Project description:BackgroundWeight gained in young adulthood often persists throughout later life with associated chronic disease risk. Despite this, current population prevention strategies are not specifically designed for young adults.ObjectiveWe designed and assessed the efficacy of an mHealth prevention program, TXT2BFiT, in preventing excess weight gain and improving dietary and physical activity behaviors in young adults at increased risk of obesity and unhealthy lifestyle choices.MethodsA two-arm, parallel-group randomized controlled trial was conducted. Subjects and analyzing researchers were blinded. A total of 250 18- to 35-year-olds with a high risk of weight gain, a body mass index (BMI) of 23.0 to 24.9 kg/m(2) with at least 2 kg of weight gain in the previous 12 months, or a BMI of 25.0 to 31.9 kg/m(2) were randomized to the intervention or control group. In the 12-week intervention period, the intervention group received 8 text messages weekly based on the transtheoretical model of behavior change, 1 email weekly, 5 personalized coaching calls, a diet booklet, and access to resources and mobile phone apps on a website. Control group participants received only 4 text messages and printed dietary and physical activity guidelines. Measured body weight and height were collected at baseline and at 12 weeks. Outcomes were assessed via online surveys at baseline and at 12 weeks, including self-reported weight and dietary and physical activity measures.ResultsA total of 214 participants-110 intervention and 104 control-completed the 12-week intervention period. A total of 10 participants out of 250 (4.0%)-10 intervention and 0 control-dropped out, and 26 participants (10.4%)-5 intervention and 21 control-did not complete postintervention online surveys. Adherence to coaching calls and delivery of text messages was over 90%. At 12 weeks, the intervention group were 2.2 kg (95% CI 0.8-3.6) lighter than controls (P=.005). Intervention participants consumed more vegetables (P=.009), fewer sugary soft drinks (P=.002), and fewer energy-dense takeout meals (P=.001) compared to controls. They also increased their total physical activity by 252.5 MET-minutes (95% CI 1.2-503.8, P=.05) and total physical activity by 1.3 days (95% CI 0.5-2.2, P=.003) compared to controls.ConclusionsThe TXT2BFiT low-intensity intervention was successful in preventing weight gain with modest weight loss and improvement in lifestyle behaviors among overweight young adults. The short-term success of the 12-week intervention period shows potential. Maintenance of the behavior change will be monitored at 9 months.Trial registrationTrial registrationThe Australian New Zealand Clinical Trials Registry ACTRN12612000924853; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000924853 (Archived by WebCite at http://www.webcitation.org/6Z6w9LlS9).

Dataset Information

The 40-Something randomized controlled trial to prevent weight gain in mid-age women.

Background

Methods and design

Discussion

Trial registration

Publications

The 40-Something randomized controlled trial to prevent weight gain in mid-age women.

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