The Effectiveness and Cost-Effectiveness of the ‘Walk with Me’ Peer-Led Walking Intervention to Increase Physical Activity in Inactive Older Adults: Study Protocol for a Randomised Controlled Trial

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

In this study, the methodology was relatively well organized, and it is likely to be a meaningful study to evaluate community-run exercise interventions. If the following few things are supplemented, it will be a little more complete.

 

Line 113. Depression status from participants is also consider as eligibility criteria?

Line 163. Please provide validity or reliability of the pedometer (Yamax).

Line 211. [ Peer Mentors]. What kind of strategies will you have under hot or cold weather? Under these conditions outdoor walking would be difficult especially in old adults. Also, education for safety for mentors should be included. The mentors would contact the participants and they may need to consult the minor health problems.

Line 287. The reference [42] is for over 70 years old. Your participants are over 60 years, so you may consider to use Senior Fitness Test (SFT) to evaluate fitness factors.

Line 368. [Sample size]. Older adults sometimes have to terminate the intervention due to health problems from their spouse, siblings as well as themselves. Should be consider this kind of drop rate.

Author Response

Reviewer 1

In this study, the methodology was relatively well organized, and it is likely to be a meaningful study to evaluate community-run exercise interventions. If the following few things are supplemented, it will be a little more complete.

 

Comment 1: Line 113. Depression status from participants is also consider as eligibility criteria?

Response 1: Depression is not included as an eligibility criteria within this study. We do not believe it impacts on an individual ability to give fully informed consent.

 

Comment 2: Line 163. Please provide validity or reliability of the pedometer (Yamax).

Response 2: Thank you for this comment. The Yamax Pedometer is not used to assess physical activity, so validity and reliability are not as important an issue as other studies, where it is used as an outcome measure. Nonetheless, we recognize reliability is important when using a pedometer to self-monitor. We have therefore included a reference as suggested (reference 26, page 4).

 

Comment 3: Line 211. [ Peer Mentors]. What kind of strategies will you have under hot or cold weather? Under these conditions outdoor walking would be difficult especially in old adults. Also, education for safety for mentors should be included. The mentors would contact the participants and they may need to consult the minor health problems.

Response 3: This study is not being implemented in a climate that experiences extremes of weather conditions. Peer mentors are trained to utilize strategies to tailor the delivery to the circumstances participants face. This includes the potential to use indoor walking venues (e.g. shopping centres) if the weather is inclement or icy. This is part of the advice given around safety, including choosing appropriate walking destinations and an awareness of signs and symptoms of an adverse event. This has been noted in the text (page 5, lines 241-246).

 

Comment 4: Line 287. The reference [42] is for over 70 years old. Your participants are over 60 years, so you may consider to use Senior Fitness Test (SFT) to evaluate fitness factors.

Response 4: We appreciate this insight. Unfortunately, it is not possible to change the outcomes, as this study has been funded on the basis of the proposed outcomes.

 

Comments 5: Line 368. [Sample size]. Older adults sometimes have to terminate the intervention due to health problems from their spouse, siblings as well as themselves. Should be consider this kind of drop rate.

Response 5: We have included a 20% allowance for dropout within the sample size calculation (noted in line 388). This is based on previous research on this population. Reasons for dropout will be recorded and this is noted on page 8, line 394.

Reviewer 2 Report

Comments and Suggestions for Authors

Authors presented a study protocol of a randomised controlled trial to assess the effectiveness of the ‘Walk with Me’ peer-led walking intervention to increase physical activity in inactive older adults.

There is a similar protocol (10.1186/s40814-018-0308-2 and Development of the ‘Walk with Me’ peer-led walking intervention to increase physical activity in inactive older adults - Peer-led walking programme to increase physical activity in inactive 60- to 70-year-olds: Walk with Me pilot RCT - NCBI Bookshelf (nih.gov)) please explain differences. 

 

Author Response

Reviewer 2

Comment 1: Authors presented a study protocol of a randomised controlled trial to assess the effectiveness of the ‘Walk with Me’ peer-led walking intervention to increase physical activity in inactive older adults.

There is a similar protocol (10.1186/s40814-018-0308-2 and Development of the ‘Walk with Me’ peer-led walking intervention to increase physical activity in inactive older adults - Peer-led walking programme to increase physical activity in inactive 60- to 70-year-olds: Walk with Me pilot RCT - NCBI Bookshelf (nih.gov)) please explain differences. 

 

Response 1: Thank you for this comment. The protocol referred to was for a preceding feasibility study. The results of the feasibility study were published, and we cite this in the current manuscript (Reference 14) as the basis for this proposed fully powered RCT.

Reviewer 3 Report

Comments and Suggestions for Authors

This protocol is a well-designed and very well-written, detailed, RCT study plan to test the effectiveness and cost-effectiveness of the "Walk with Me" peer-led walking intervention to increase physical activity in inactive older adults. To enhance clarity and facilitate reader comprehension while ensuring faithful protocol reproduction, please consider the following points:

 

Overall Comments:

Following the SPIRIT statement, including a schematic diagram illustrating the flow of participant timelines, enrollment, allocation, intervention, and assessment would enhance understanding. Supplementing the SPIRIT statement checklist as additional material would increase the reliability of this protocol.

Please unify the capitalization of the words in each item title, as they are in mixed case.

 

Abstract:

While it is indicated that socially and economically disadvantaged older adults are a challenge in the Introduction, I believe that explicitly stating the issue of "health disparity" would emphasize the purpose, significance, and importance of this study.

 

Introduction:

Line 55: The term "Umbrella review" can be used directly, as readers should understand it.

 

Materials and Methods:

Study Design

Lines 78–79: Since the background involves the issue of an increasing population of individuals aged 65 and above, explaining the choice of 60 years and above as the target age group would enhance clarity.

 

Study Setting and Recruitment

Lines 98–103: How will addresses (for mailing purposes) of residents living in socioeconomically disadvantaged areas be obtained? Is it permissible to use addresses of patients obtained by general practices for research purposes? Also, it seems that there are incentives for mentors, but it would be helpful to describe the incentives for participants (if there are none) to facilitate understanding.

 

Allocation and Randomization

Line 145: "GP" is mentioned for the first time, please spell it out.

 

Walk with Me Intervention

Lines 174–175: Although it mentions "regularly," providing an approximate frequency would make it easier to visualize.

 

Peer Mentors

Line 232: Is a Mentor different from a Peer Mentor?

 

Outcome Measures

Lines 274–280: There is a discrepancy between the minimum wear days for the accelerometer (4 days or more) and the number of days adopted as valid data (5 days or more), so please confirm that each value is correct.

 

Health Economic Evaluation

Lines 308–317: It might be beneficial to indicate the cost threshold per QALY that signifies a significant or inferior effect.

Author Response

Reviewer 3

This protocol is a well-designed and very well-written, detailed, RCT study plan to test the effectiveness and cost-effectiveness of the "Walk with Me" peer-led walking intervention to increase physical activity in inactive older adults. To enhance clarity and facilitate reader comprehension while ensuring faithful protocol reproduction, please consider the following points:

 

Overall Comments:

Comment 1: Following the SPIRIT statement, including a schematic diagram illustrating the flow of participant timelines, enrollment, allocation, intervention, and assessment would enhance understanding. Supplementing the SPIRIT statement checklist as additional material would increase the reliability of this protocol.

Response 1: Thank you for this comment. A flow diagram to illustrate participant timelines has been added as suggested (Figure 1). A SPIRIT checklist has also been added as supplementary material file 1. These are noted in the text on lines 98 and 82 respectively.

 

Comment 2: Please unify the capitalization of the words in each item title, as they are in mixed case.

Response 2: Thank you for pointing this out. We have reviewed and amended as suggested.

 

Abstract:

Comment 3: While it is indicated that socially and economically disadvantaged older adults are a challenge in the Introduction, I believe that explicitly stating the issue of "health disparity" would emphasize the purpose, significance, and importance of this study.

Response 3: We have removed this term and added in “health inequalities”, which is the term used in the UK, where the study is based (Line 26).

 

Introduction:

Comment 4: Line 55: The term "Umbrella review" can be used directly, as readers should understand it.

Response 4: We have made the suggested amendment

 

Materials and Methods:

Study Design

Comment 5: Lines 78–79: Since the background involves the issue of an increasing population of individuals aged 65 and above, explaining the choice of 60 years and above as the target age group would enhance clarity.

 Response 5: We have added line to enhance clarity on while 60 years and above was used (Line 87, page 2).

 

Study Setting and Recruitment

Comment 6: Lines 98–103: How will addresses (for mailing purposes) of residents living in socioeconomically disadvantaged areas be obtained? Is it permissible to use addresses of patients obtained by general practices for research purposes? Also, it seems that there are incentives for mentors, but it would be helpful to describe the incentives for participants (if there are none) to facilitate understanding.

Response 6:

The authors have added clarification on how mailings to participants are handled (line 109, page 3). In summary, study staff do not have access to patient identifiable information held at the practice. Practice staff will identify potential participants from their patient lists and send the postal invite on behalf of the study team. Practices based in the target communities will be selected. Study staff will only have access to personal identifiable information for individual’s that return a reply slip.

There are no incentives given to participants and this has been noted in the study setting and recruitment section (page 3, line 113).

 

Allocation and Randomization

Comment 7: Line 145: "GP" is mentioned for the first time, please spell it out.

Response 7: We have amended to the full phrase ‘general practitioner’.

 

Walk with Me Intervention

Comment 8: Lines 174–175: Although it mentions "regularly," providing an approximate frequency would make it easier to visualize.

Response 8:  The authors have added to the sentence to confirm this is “once a week”.

 

Peer Mentors

Comment 9: Line 232: Is a Mentor different from a Peer Mentor?

Response 9: In the context of a section on peer mentors, we felt shortening the phrase to mentors would be understood. In light of the comment, we have amended this to ‘Peer mentors…’.

 

Outcome Measures

Comment 10: Lines 274–280: There is a discrepancy between the minimum wear days for the accelerometer (4 days or more) and the number of days adopted as valid data (5 days or more), so please confirm that each value is correct.

Response 10:  We have amended this to five days.

 

Health Economic Evaluation

Comment 11: Lines 308–317: It might be beneficial to indicate the cost threshold per QALY that signifies a significant or inferior effect.

Response 11: We have noted in the health economics section that the current NICE threshold is £20,000 per QALY (line 325, Page 7).

Round 2

Reviewer 2 Report

Comments and Suggestions for Authors

Thank You