Get Healthy, Stay Healthy: Evaluation of the Maintenance of Lifestyle Changes Six Months After an Extended Contact Intervention

Background Extended intervention contact after an initial, intensive intervention is becoming accepted as best practice in behavioral weight control interventions. Whether extended contact mitigates weight regain in the longer term or it simply delays weight regain until after the extended intervention contact ceases is not clear. Objective This study aimed to evaluate, in multiple ways, maintenance of weight, diet, and physical activity outcomes following Get Healthy, Stay Healthy (GHSH), a text message–delivered extended contact intervention. Methods Clients completing the Get Healthy Service (GHS) lifestyle telephone coaching program were randomized to receive GHSH (n=114) or standard care (no additional contact, n=114) and were assessed at baseline (following completion of GHS), 6 months (following completion of GHSH), and 12 months (noncontact maintenance follow-up). At all 3 assessments, participants self-reported their body weight, waist circumference, physical activity (walking and moderate and vigorous sessions/week), and dietary behaviors (fruit and vegetable serves/day, cups of sweetened drinks per day, takeaway meals per week; fat, fiber, and total indices from the Fat and Fiber Behavior Questionnaire). Moderate-to-vigorous physical activity (MVPA) was also assessed via accelerometry. Maintenance was examined multiple ways: (1) using traditional methods to assess and compare group averages after some period of noncontact (ie, at 12 months), (2) using a novel approach to assess and compare group average changes over the first 6 months of noncontact, and (3) exploring individual participant changes (increase/decrease/no change) over the first 6 months of noncontact. Results Retention over the 12-month trial was high (92.5%, 211/228). Participants had a mean (SD) age of 53.4 (SD 12.3) years and a baseline body mass index of 29.2 (SD 5.9) kg/m2. The between-group differences detected at 6 months were still present and statistically significant at 12 months for bodyweight (−1.33 kg [−2.61 to −0.05]) and accelerometer-assessed MVPA (24.9 min/week [5.8-44.0]). None of the other outcomes were significantly favored compared with the control group at 12 months. Changes over their first 6 months of noncontact for the GHSH group were significantly better than the control group in terms of accelerometer-measured MVPA and self-reported moderate activity (other differences between the groups were all nonsignificant). In addition to the maintenance seen in the group averages, most intervention participants had maintained their behavioral outcomes during the first 6 months of noncontact. Conclusions The GHSH participants were better off relative to where they were initially, and relative to their counterparts, not receiving extended contact in terms of MVPA. However, based on the between-group difference in bodyweight over the first 6 months of noncontact, GHSH does appear to simply delay the inevitable weight regain. However, this delay in weight regain, coupled with sustained improvements in MVPA, has public health benefits. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12613000949785; https://www.anzctr.org. au/Trial/Registration/TrialReview.aspx?id=364821&isReview=true


INTRODUCTION 2a) In INTRODUCTION: Scientific background and explanation of rationale
Does your paper address subitem 1b-v? "the GHSH participants were better off relative to where they were initially, and relative to their counterparts, not receiving extended contact in terms of MVPA.
However, based on the between-group difference in bodyweight over the first 6 months of noncontact, GHSH does appear to simply delay the inevitable weight regain. However, this delay in weight regain, coupled with sustained improvements in MVPA, has public health benefits" 2a-i) Problem and the type of system/solution 2b) In INTRODUCTION: Specific objectives or hypotheses Does your paper address subitem 2a-i? * It "is not known is whether extended contact helps mitigate weight regain in the longer-term or whether it simply delays weight regain until after the extended intervention contact ceases" 2a-ii) Scientific background, rationale: What is known about the (type of) system Does your paper address subitem 2a-ii? * Method 1 "establishes whether an intervention has a lasting effect, after allowing sometime for intervention recipients to relapse." Method 2 "adds to the previous by determining whether the degree of changes after extended-contact intervention are any different to changes that naturally occur over the same amount of noncontact time without extended contact." Method 3 aims "to explore to what extent non substantial changes in group averages reflect all or most participants making no changes or are due to large increases by some participants being offset by large decreases by other participants" METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 2b? * "This paper aims to evaluate maintenance beyond the period of the GHSH extended contact intervention in multiple ways. First, we used the traditional method of assessing and comparing changes from baseline contemporaneously after some period of noncontact (ie, at 12 months, which is after 6 months of noncontact for the intervention group and after 12 months of noncontact for the control group). Second, we used a novel approach to directly assess and compare the degree of changes over the first 6 months of noncontact between the intervention group (between 6 and 12 months) and the control group (between baseline and 6 months). . Finally, both of these maintenance perspectives consider only changes at the group level.
We ,therefore, also examined individual-level changes (personal increase/decrease/no change) over the first 6 months of noncontact" Does your paper address CONSORT subitem 3a? * 5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework Does your paper address subitem 5-viii? * Participants received telephone calls and text messages. See protocol and main outcomes paper.

5-ix) Describe use parameters
Does your paper address subitem 5-ix? Participants received telephone calls and text messages. See protocol and main outcomes paper.

5-x) Clarify the level of human involvement
Does your paper address subitem 5-x? This manuscript is assessing maintenance of outcomes after the end of the intervention. Participants received 2 telephone calls and text messages during the initial intervention. See protocol and main outcomes paper. 5-xi) Report any prompts/reminders used 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Does your paper address subitem 5-xi? * This manuscript is assessing maintenance of outcomes after the end of the intervention. Participants received 2 telephone calls and text messages during the initial intervention. See protocol and main outcomes paper.

5-xii) Describe any co-interventions (incl. training/support)
Does your paper address subitem 5-xii? * This manuscript is assessing maintenance of outcomes after the end of the intervention. See protocol and main outcomes paper.
Does your paper address CONSORT subitem 6a? * See protocol and main outcomes paper "Primary outcomes of body weight, waist circumference, physical activity (walking, moderate, and vigorous sessions/week), and dietary behaviors (fruit and vegetable serves/day, cups of sweetened drinks per day, takeaway meals per week; fat, fiber and total indices from the Fat and Fiber Behavior Questionnaire) were assessed via self-report before (baseline) and after (6-months) extended contact (with moderatevigorous physical activity (MVPA) also assessed via accelerometry)." 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed Does your paper address subitem 6a-i? Not applicable 6b) Any changes to trial outcomes after the trial commenced, with reasons 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Does your paper address subitem 6a-ii? See protocol and main outcomes paper. "Participants selected their desired number of text messages (from 3-13 per fortnight) ,timing of texts (eg, 6 am), and type of texts." 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Does your paper address subitem 6a-iii? See main outcomes paper. This manuscript is assessing maintenance of outcomes after the end of the intervention 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed 7b) When applicable, explanation of any interim analyses and stopping guidelines Does your paper address CONSORT subitem 6b? * No changes 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Does your paper address subitem 7a-i? See protocol paper 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 7b? * Not applicable Does your paper address CONSORT subitem 8a? * "Eligible consenting participants were randomized in a 1:1 ratio to the GHSH intervention and control groups, via a randomization website, by a research assistant with no involvement in participant recruitment." Does your paper address CONSORT subitem 8b? * "Randomization was across 2 strata (≥ or < the median of 3 kg weight loss during GHS)." 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how "Statistical analyses were performed using SPSS Statistics version22 (IBM, USA) and STATA version 13 (StataCorp LP, USA).Significance was set at P<.05, 2-tailed. Changes within groups were assessed using paired t tests. All differences between groups were estimated adjusting for the same potential confounders as per the main outcome evaluation of the GHSH intervention [12].
Differences between the groups in their changes (for all outcomes and all time frames) were assessed using separate linear regression models adjusting for baseline values of the outcome and confounders. When assessing changeover the period from baseline to 12 months, baseline values were taken as the beginning of the GHSH evaluation. When assessing changes over the first 6 months of noncontact, baseline values were taken as the beginning of the GHSH evaluation for controls or at 6 months for the intervention group. 13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center 16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups Does your paper address CONSORT subitem 15? * Table 1 15-i) Report demographics associated with digital divide issues Does your paper address subitem 15-i? * Not applicable 16-i) Report multiple "denominators" and provide definitions 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Does your paper address subitem 16-i? * The number of participants in each group included are listed for each variable in figures 1 -3 16-ii) Primary analysis should be intent-to-treat Does your paper address subitem 16-ii? See main outcomes paper "missing data were excluded and analyses were based on intention-to-treat" Does your paper address CONSORT subitem 17a? * See " Table 2. Difference in study outcomes between the Get Healthy, Stay Healthy (GHSH) extended contact group (n=114) and control group (n=114) adjusted for baseline values of the outcome and potential confounders" 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory 17a-i) Presentation of process outcomes such as metrics of use and intensity of use Does your paper address subitem 17a-i?  NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Does your paper address subitem 22-i? * "the present evaluation showed that these between-group differences were still present and statistically significant at 12 months. None of the other outcomes, such as self-reported physical activity and dietary behaviors, were significantly favored compared with the control group at 12 months." 22-ii) Highlight unanswered new questions, suggest future research