ObesityASPIRENCT00967668
Coaching Veterans to Healthy Weights and Wellness
A study testing Small change approach to improve physical activity and diet in people with Obesity, run by US Department of Veterans Affairs at 2 sites in United States.
Trial summary
ASPIRE has completed enrollment of patients at the Ann Arbor and Cleveland Medical Centers in a study that is examining the impact of an innovative approach to weight loss ("Aspiring to Lifelong Health in VA", aka "ASPIRE-VA"). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Small change approach to improve physical activity and diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 481 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current patient at Ann Arbor or Cleveland medical center.
- Current provider- or self-referral to MOVE! program and eligible to participate in MOVE!
- 18 years of age and older
- Able to communicate in English
- Report being able to walk 10 minutes continuously without sitting down to rest
- Competent to provide written informed consent
Who cannot join
- Enrolled in another research study involving weight loss, nutrition, or physical activity
- Being treated for weight loss or on weight loss medications (OTC or prescribed)
- Are currently pregnant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
VA Medical Center, Cleveland
Cleveland, Ohio, 44106
About this study
Official title: ASPIRE: Coaching Veterans to Healthy Weights and Wellness
ASPIRE has completed enrollment of patients at the Ann Arbor and Cleveland Medical Centers in a study that is examining the impact of an innovative approach to weight loss ("Aspiring to Lifelong Health in VA", aka "ASPIRE-VA"). ASPIRE-VA has 3 key features: 1) lifestyle coaches who encourage behavior change through a "small steps" approach; 2) a simplified "Stoplight" diet; and 3) user-friendly "enhanced" pedometers to help participants monitor their physical activity.
Read the detailed description
Background:
Nearly 78% of Veterans are overweight or obese, imposing a tremendous burden on the Veterans Health Administration (VHA) healthcare system for the treatment of obesity-related chronic disease and disability. While weight management treatment has been implemented in VHA, program data shows low enrollment, participation, and weight loss. Traditional behavioral weight loss trials frequently exclude individuals with multiple chronic health conditions. Additionally, men are less likely than women to participate in these trials. New weight loss approaches may be needed to treat these populations.
Objectives:
To test whether a small-changes intervention (The Aspiring to Lifelong Health Program; aka ASPIRE), delivered in groups or individually via telephone, promotes greater weight loss than standard obesity treatment in a predominantly male, high-risk Veteran population. Data were collected in 2010-13.
Methods:
A three-arm, 12-month randomized pragmatic effectiveness trial was conducted. Participants were recruited from MOVE! referrals and randomly assigned to one of three programs: the 12-month ASPIRE weight loss program delivered 1) individually over the phone (ASPIRE-Phone) or 2) in-person group sessions (ASPIRE-Group); compared to 3) Veteran Health Administration's VHA standard weight loss program, MOVE!. Participants in the ASPIRE arms met with health coaches weekly in months 1-3, bi-weekly in months 4-9, and monthly in months 10-12. Usual care participants met weekly for 12 weeks with limited options for follow-up care. The ASPIRE program had distinct characteristics: 1) the opportunity for most participants to work with one lifestyle coach throughout treatment, 2) an emphasis on behavior change through a "small steps" approach; 3) the prominence of self-monitoring both physical activity and food intake as a weight loss tool; and 4) the addition of a purely phone based option. Assessments that included the collection of weight, waist circumference and lab values, along with questionnaires, were conducted at baseline, 3-months and 12-months. ASPIRE also added a follow-up component to the study, which was offered to patients at their 12-month assessment. For phone and group patients, it consisted of sessions every other month and an assessment at 18 and 24 months. Usual care patients participated in the assessments only.
Phone-based Interviews were conducted shortly after the 3-month assessment with 19 patients in the ASPIRE phone arm and with 16 in the ASPIRE group arm. These interviews were recorded, transcribed and analyzed using NVivo qualitative software to identify themes associated with successful weight loss at 3-month.
Approximately 5% of all phone and group intervention sessions were audio-recorded. An expert rater used a checklist to rate session fidelity. A second rater independently assessed 30% of the recorded sessions to establish inter-rater reliability. The checklist was psychometrically validated. It was hypothesized that greater adherence to core behavioral change processes and patient-centered communication strategies by the interventionists would be associated with higher levels of weight loss.
Using intention-to-treat principles guide all analyses. The primary outcome was weight change and secondary outcomes included changes in anthropometric (e.g., waist circumference), behavioral, fitness, psychosocial, and physiological measures. The primary analytic approach relied on a linear mixed-effects model with baseline, 3- and 12-month outcomes (e.g., weight) as dependent variables, with each subject as a random intercept to adjust for within-patient correlation of the repeated measures, fixed predictors of study arm indicators, 3- and 12-month time indicators, and time-by-study arm interactions.
Status:
All coaching and assessments are complete. A design and rationale paper has been published, a paper highlighting 12-month results is in revision. Papers on fidelity, qualitative findings, the role of mental illness and binge eating on weight loss are in progress. Analyses of 24-month data are underway.
- Conditions
- Obesity
- Being tested
- Small change approach to improve physical activity and diet, MOVE! Usual Care
- Keywords
- Counseling, Veterans, Weight loss, Physical activity, Diet
- Medical subject headings
- Obesity, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small change approach to improve physical activity and dietBehavioural
The "Aspire to Lifelong Health" (ASPIRE) initial treatment program draws on the strengths of traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week in the program, participants use a food diary to track caloric intake and a pedometer to log their daily physical activity (step counts). Baseline information provides a starting point for participants and their Lifestyle Coach to set one small, but potentially permanent, change in daily food choices and physical activity to promote a caloric deficit. Small changes are cumulative over the weeks and the participant makes their own goals within the context of their own lifestyle.
MOVE! Usual CareBehavioural
The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care.
| Study group | Role | What they receive |
|---|---|---|
| ASPIRE-Phone Lifestyle Coaching | Experimental | Phone-based coaching using small change approach to improve physical activity and diet. Initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA). Receives: Behavioral: Small change approach to improve physical activity and diet |
| ASPIRE-Group Lifestyle Coaching | Experimental | On-site weekly group visits using small change approach to improve physical activity and diet. Initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA). Receives: Behavioral: Small change approach to improve physical activity and diet |
| MOVE! Usual Care | Active comparator | Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support Receives: Behavioral: MOVE! Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Expected weight change from baseline to 12 months in kilograms based on linear mixed-effects model using all available data
Measured: 12 months after enrollment
Secondary outcomes (1)
Change in Weight
Expected weight change from baseline to 24 months in kilograms based on linear mixed-effects model using all available data. Statistical analyses methods are the same as for the 12-month outcome.
Measured: 24 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startJan 2010
- Primary completionOct 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 481 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Julie C Lowery, PhD MHSA, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967668
- Sponsor's protocol ID
- IBB 09-034
- Acronym
- ASPIRE
- Status last verified
- Feb 2014
- First submitted
- 26 Aug 2009
- Last updated
- 24 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lutes LD, Dinatale E, Goodrich DE, Ronis DL, Gillon L, Kirsh S, Richardson CR, Damschroder LJ. A randomized trial of a small changes approach for weight loss in veterans: design, rationale, and baseline characteristics of the ASPIRE-VA trial. Contemp Clin Trials. 2013 Jan;34(1):161-72. doi: 10.1016/j.cct.2012.09.007. Epub 2012 Oct 4.
PubMed 23041618Damschroder LJ, Lutes LD, Kirsh S, Kim HM, Gillon L, Holleman RG, Goodrich DE, Lowery JC, Richardson CR. Small-changes obesity treatment among veterans: 12-month outcomes. Am J Prev Med. 2014 Nov;47(5):541-53. doi: 10.1016/j.amepre.2014.06.016. Epub 2014 Sep 10.
PubMed 25217098Janney CA, Masheb RM, Lutes LD, Holleman RG, Kim HM, Gillon LR, Damschroder LJ, Richardson CR. Mental health and behavioral weight loss: 24-month outcomes in Veterans. J Affect Disord. 2017 Jun;215:197-204. doi: 10.1016/j.jad.2017.03.003. Epub 2017 Mar 11.
PubMed 28340446Damschroder LJ, Goodrich DE, Kim HM, Holleman R, Gillon L, Kirsh S, Richardson CR, Lutes LD. Development and validation of the ASPIRE-VA coaching fidelity checklist (ACFC): a tool to help ensure delivery of high-quality weight management interventions. Transl Behav Med. 2016 Sep;6(3):369-85. doi: 10.1007/s13142-015-0336-x.
PubMed 27528526Vimalananda V, Damschroder L, Janney CA, Goodrich D, Kim HM, Holleman R, Gillon L, Lutes L. Weight loss among women and men in the ASPIRE-VA behavioral weight loss intervention trial. Obesity (Silver Spring). 2016 Sep;24(9):1884-91. doi: 10.1002/oby.21574. Epub 2016 Aug 4.
PubMed 27488278Masheb RM, Lutes LD, Kim HM, Holleman RG, Goodrich DE, Janney CA, Kirsh S, Higgins DM, Richardson CR, Damschroder LJ. Weight loss outcomes in patients with pain. Obesity (Silver Spring). 2015 Sep;23(9):1778-84. doi: 10.1002/oby.21160. Epub 2015 Aug 3.
PubMed 26237112
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASPIRE: Coaching Veterans to Healthy Weights and Wellness
- ClinicalTrials.gov ID
- NCT00967668
- Acronym / sponsor ID
- ASPIRE / IBB 09-034
- Conditions
- Obesity
- Keywords
- Counseling, Veterans, Weight loss, Physical activity, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 481 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jan 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Aug 2009 (estimated)
- Results
- Posted 29 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ASPIRE has completed enrollment of patients at the Ann Arbor and Cleveland Medical Centers in a study that is examining the impact of an innovative approach to weight loss ("Aspiring to Lifelong Health in VA", aka "ASPIRE-VA"). ASPIRE-VA has 3 key features: 1) lifestyle coaches who encourage behavior change through a "small steps" approach; 2) a simplified "Stoplight" diet; and 3) user-friendly "enhanced" pedometers to help participants monitor their physical activity.
Detailed description
Background:
Nearly 78% of Veterans are overweight or obese, imposing a tremendous burden on the Veterans Health Administration (VHA) healthcare system for the treatment of obesity-related chronic disease and disability. While weight management treatment has been implemented in VHA, program data shows low enrollment, participation, and weight loss. Traditional behavioral weight loss trials frequently exclude individuals with multiple chronic health conditions. Additionally, men are less likely than women to participate in these trials. New weight loss approaches may be needed to treat these populations.
Objectives:
To test whether a small-changes intervention (The Aspiring to Lifelong Health Program; aka ASPIRE), delivered in groups or individually via telephone, promotes greater weight loss than standard obesity treatment in a predominantly male, high-risk Veteran population. Data were collected in 2010-13.
Methods:
A three-arm, 12-month randomized pragmatic effectiveness trial was conducted. Participants were recruited from MOVE! referrals and randomly assigned to one of three programs: the 12-month ASPIRE weight loss program delivered 1) individually over the phone (ASPIRE-Phone) or 2) in-person group sessions (ASPIRE-Group); compared to 3) Veteran Health Administration's VHA standard weight loss program, MOVE!. Participants in the ASPIRE arms met with health coaches weekly in months 1-3, bi-weekly in months 4-9, and monthly in months 10-12. Usual care participants met weekly for 12 weeks with limited options for follow-up care. The ASPIRE program had distinct characteristics: 1) the opportunity for most participants to work with one lifestyle coach throughout treatment, 2) an emphasis on behavior change through a "small steps" approach; 3) the prominence of self-monitoring both physical activity and food intake as a weight loss tool; and 4) the addition of a purely phone based option. Assessments that included the collection of weight, waist circumference and lab values, along with questionnaires, were conducted at baseline, 3-months and 12-months. ASPIRE also added a follow-up component to the study, which was offered to patients at their 12-month assessment. For phone and group patients, it consisted of sessions every other month and an assessment at 18 and 24 months. Usual care patients participated in the assessments only.
Phone-based Interviews were conducted shortly after the 3-month assessment with 19 patients in the ASPIRE phone arm and with 16 in the ASPIRE group arm. These interviews were recorded, transcribed and analyzed using NVivo qualitative software to identify themes associated with successful weight loss at 3-month.
Approximately 5% of all phone and group intervention sessions were audio-recorded. An expert rater used a checklist to rate session fidelity. A second rater independently assessed 30% of the recorded sessions to establish inter-rater reliability. The checklist was psychometrically validated. It was hypothesized that greater adherence to core behavioral change processes and patient-centered communication strategies by the interventionists would be associated with higher levels of weight loss.
Using intention-to-treat principles guide all analyses. The primary outcome was weight change and secondary outcomes included changes in anthropometric (e.g., waist circumference), behavioral, fitness, psychosocial, and physiological measures. The primary analytic approach relied on a linear mixed-effects model with baseline, 3- and 12-month outcomes (e.g., weight) as dependent variables, with each subject as a random intercept to adjust for within-patient correlation of the repeated measures, fixed predictors of study arm indicators, 3- and 12-month time indicators, and time-by-study arm interactions.
Status:
All coaching and assessments are complete. A design and rationale paper has been published, a paper highlighting 12-month results is in revision. Papers on fidelity, qualitative findings, the role of mental illness and binge eating on weight loss are in progress. Analyses of 24-month data are underway.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASPIRE-Phone Lifestyle Coaching | Experimental | Behavioral: Small change approach to improve physical activity and dietPhone-based coaching using small change approach to improve physical activity and diet. Initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA). |
| ASPIRE-Group Lifestyle Coaching | Experimental | Behavioral: Small change approach to improve physical activity and dietOn-site weekly group visits using small change approach to improve physical activity and diet. Initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA). |
| MOVE! Usual Care | Active comparator | Behavioral: MOVE! Usual CareUsual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Current patient at Ann Arbor or Cleveland medical center.
- Current provider- or self-referral to MOVE! program and eligible to participate in MOVE!
- 18 years of age and older
- Able to communicate in English
- Report being able to walk 10 minutes continuously without sitting down to rest
Key exclusion criteria (3 listed)
- Enrolled in another research study involving weight loss, nutrition, or physical activity
- Being treated for weight loss or on weight loss medications (OTC or prescribed)
- Are currently pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small change approach to improve physical activity and dietThe "Aspire to Lifelong Health" (ASPIRE) initial treatment program draws on the strengths of traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week in the program, participants use a food diary to track caloric intake and a pedometer to log their daily physical activity (step counts). Baseline information provides a starting point for participants and their Lifestyle Coach to set one small, but potentially permanent, change in daily food choices and physical activity to promote a caloric deficit. Small changes are cumulative over the weeks and the participant makes their own goals within the context of their own lifestyle. | Behavioural | ASPIRE-Group Lifestyle Coaching, ASPIRE-Phone Lifestyle Coaching |
| MOVE! Usual CareThe MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care. | Behavioural | MOVE! Usual Care |
Primary outcome
Change in Weight
Time frame: 12 months after enrollment
Expected weight change from baseline to 12 months in kilograms based on linear mixed-effects model using all available data
1 secondary outcome
Change in Weight
Time frame: 24 months after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23041618Lutes LD, Dinatale E, Goodrich DE, Ronis DL, Gillon L, Kirsh S, Richardson CR, Damschroder LJ. A randomized trial of a small changes approach for weight loss in veterans: design, rationale, and baseline characteristics of the ASPIRE-VA trial. Contemp Clin Trials. 2013 Jan;34(1):161-72. doi: 10.1016/j.cct.2012.09.007. Epub 2012 Oct 4.
- Results publication: PubMed 25217098Damschroder LJ, Lutes LD, Kirsh S, Kim HM, Gillon L, Holleman RG, Goodrich DE, Lowery JC, Richardson CR. Small-changes obesity treatment among veterans: 12-month outcomes. Am J Prev Med. 2014 Nov;47(5):541-53. doi: 10.1016/j.amepre.2014.06.016. Epub 2014 Sep 10.
- Derived from this study: PubMed 28340446Janney CA, Masheb RM, Lutes LD, Holleman RG, Kim HM, Gillon LR, Damschroder LJ, Richardson CR. Mental health and behavioral weight loss: 24-month outcomes in Veterans. J Affect Disord. 2017 Jun;215:197-204. doi: 10.1016/j.jad.2017.03.003. Epub 2017 Mar 11.
- Derived from this study: PubMed 27528526Damschroder LJ, Goodrich DE, Kim HM, Holleman R, Gillon L, Kirsh S, Richardson CR, Lutes LD. Development and validation of the ASPIRE-VA coaching fidelity checklist (ACFC): a tool to help ensure delivery of high-quality weight management interventions. Transl Behav Med. 2016 Sep;6(3):369-85. doi: 10.1007/s13142-015-0336-x.
- Derived from this study: PubMed 27488278Vimalananda V, Damschroder L, Janney CA, Goodrich D, Kim HM, Holleman R, Gillon L, Lutes L. Weight loss among women and men in the ASPIRE-VA behavioral weight loss intervention trial. Obesity (Silver Spring). 2016 Sep;24(9):1884-91. doi: 10.1002/oby.21574. Epub 2016 Aug 4.
- Derived from this study: PubMed 26237112Masheb RM, Lutes LD, Kim HM, Holleman RG, Goodrich DE, Janney CA, Kirsh S, Higgins DM, Richardson CR, Damschroder LJ. Weight loss outcomes in patients with pain. Obesity (Silver Spring). 2015 Sep;23(9):1778-84. doi: 10.1002/oby.21160. Epub 2015 Aug 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie C Lowery, PhD MHSA principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small change approach to improve physical activity and diet in people with Obesity, run by US Department of Veterans Affairs at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight (time frame: 12 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00967668, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015.