Weight Loss MaintenanceKIONCT00702455
Keep It Off: A Weight Loss Maintenance Study
A study testing Self-Directed (weight loss maintenance) and Guided (weight loss maintenance) in people with Weight Loss Maintenance, run by HealthPartners Institute at 1 site in United States.
Trial summary
The goal of this project is to test whether a phone and mail-based program designed to help people who have recently lost weight helps them keep the weight off over a 2 year period. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss Maintenance
- What is being tested?
- Self-Directed (weight loss maintenance) and Guided (weight loss maintenance)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 419 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 19 and 70
- HealthPartners members for 11 out of the past 12 months
- Have lost at least 10% of body weight in the last 12 months
Who cannot join
- Lost weight via gastric by-pass surgery
- Modified Charlson scores >=3
- Nonskin cancer
- Congestive heart failure
- Coronary heart disease
- Psychotic illness
Show all 10Show fewer
- Substance abuse
- Terminal illness
- Diagnosed eating disorder
- BMI<20.5 or >45
Trial locations and contacts
1 site in 1 country.
United States1 site
HealthPartners Research Foundation
Bloomington, Minnesota, 55425
About this study
Official title: Novel Approaches to Weight Loss Maintenance
The goal of this project is to test whether a phone and mail-based program designed to help people who have recently lost weight helps them keep the weight off over a 2 year period.
Read the detailed description
Obesity is a major public health problem in the United States. Increases in obesity prevalence over the last four decades have been dramatic in all age and social groups, heightening concern about health risks for children, adolescents, and adults. Currently, over half of US adults are overweight and upward trends in prevalence show no sign of slowing. A continuation of current trends seems quite likely to lead to substantial increases in the number of people affected by obesity-related health conditions and in premature mortality. The primary treatment for obesity continues to be behavioral weight loss therapy, an approach that uses behavioral strategies (e.g., self-monitoring, stimulus control, problem-solving) to help participants adhere to dietary and physical activity recommendations. Significant progress has been made with respect to short term weight loss research over the past twenty years, with short term weight losses approximately doubling during this time period. Unfortunately, long term weight losses remain disappointing. The typical pattern is for maximum weight loss to occur at 6 months, with weight regain following. During the year following treatment, participants typically regain 30% to 50% of their initial weight loss. Follow-up beyond 1 year indicates a pattern of continued weight gain.
Though long term weight loss maintenance remains a critical challenge for obesity treatment, important information regarding successful weight loss maintenance (e.g., high levels of physical activity, self-weighing, maintenance of a low-fat, low-calorie diet) has been derived from the National Weight Control Registry led by Drs Wing and Hill. Treatment studies have incorporated such strategies to enhance maintenance; however, the most intensive treatment phase typically occurs during weight loss initiation with the maintenance phase occurring after treatment novelty has faded. Although increasing treatment duration improves weight loss, there is a point of diminishing returns as people eventually stop attending intervention sessions. An alternative strategy to provide the critical support necessary for weight loss maintenance may be to recruit people who have recently lost weight to a maintenance-focused intervention
We will recruit up to 400 adult men and women who have recently lost at least 10% of their body weight and randomize them to either a Self-Directed Intervention or a Guided Intervention . Self- Directed participants will receive a core set of print materials describing key behaviors and skills necessary for successful weight loss maintenance and will review these materials with an intervention coach during two phone sessions. Guided participants will take part in a set of ten core phone sessions addressing key factors relevant to weight maintenance (e.g., high levels of physical activity). After completing these sessions, Guided participants will receive 8 monthly check in calls and then bimonthly calls for the rest of the study. Guided participants are also asked to report their weight weekly, either via the Keep It Off website, email or voicemail. Those who experience weight gain will receive outreach calls to assist them in reversing their recent weight gain. They will also receive bi-monthly tailored feedback reports based on whether they are maintaining, losing or gaining weight. We hypothesize that those in the Guided arm of the study will regain less weight than those in the self-directed arm.
- Conditions
- Weight Loss Maintenance
- Being tested
- Self-Directed (weight loss maintenance), Guided (weight loss maintenance)
- Keywords
- Weight loss maintenance., Interactive phone and mail-based intervention.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Directed (weight loss maintenance)Behavioural
Self- Directed participants will receive a core set of print materials describing key behaviors and skills necessary for successful weight loss maintenance and will review these materials with an intervention coach in two sessions.
Guided (weight loss maintenance)Behavioural
Guided participants will receive 8 monthly check in calls and then bimonthly calls for the rest of the study. Guided participants are also asked to report their weight weekly, either via the Keep It Off website, email or voicemail. Those who experience weight gain will receive outreach calls to assist them in reversing their weight gain.
| Study group | Role | What they receive |
|---|---|---|
| Self-Directed | Active comparator | Not described Receives: Behavioral: Self-Directed (weight loss maintenance) |
| Guided | Active comparator | Not described Receives: Behavioral: Guided (weight loss maintenance) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight: Weight change in kilograms at 24 month follow-up. We hypothesize that Guided participants will regain less weight than the Self-Directed participants.
Measured: 24 months
Secondary outcomes (1)
assessments of subgroup analysis of intervention effectiveness (e.g., BMI status, weight loss method, gender.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startSep 2006
- Primary completionFeb 2010
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Weight Loss MaintenanceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nancy E. Sherwood, PhD, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702455
- Sponsor's protocol ID
- A06-025
- Other IDs
- 1R01CA128211
- Acronym
- KIO
- Status last verified
- Nov 2012
- First submitted
- 18 Jun 2008
- Last updated
- 21 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Crain AL, Sherwood NE, Martinson BC, Jeffery RW. Mediators of Weight Loss Maintenance in the Keep It Off Trial. Ann Behav Med. 2018 Jan 5;52(1):9-18. doi: 10.1007/s12160-017-9917-x.
PubMed 28508330Crane MM, Jeffery RW, Sherwood NE. Exploring Gender Differences in a Randomized Trial of Weight Loss Maintenance. Am J Mens Health. 2017 Mar;11(2):369-375. doi: 10.1177/1557988316681221. Epub 2016 Dec 5.
PubMed 27923968Senso MM, Anderson CP, Crain AL, Sherwood NE, Martinson BC. Self-reported activity and accelerometry in 2 behavior-maintenance trials. Am J Health Behav. 2014 Mar;38(2):254-64. doi: 10.5993/AJHB.38.2.11.
PubMed 24629554
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Approaches to Weight Loss Maintenance
- ClinicalTrials.gov ID
- NCT00702455
- Acronym / sponsor ID
- KIO / A06-025
- Conditions
- Weight Loss Maintenance
- Keywords
- Weight loss maintenance., Interactive phone and mail-based intervention.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 20 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to test whether a phone and mail-based program designed to help people who have recently lost weight helps them keep the weight off over a 2 year period.
Detailed description
Obesity is a major public health problem in the United States. Increases in obesity prevalence over the last four decades have been dramatic in all age and social groups, heightening concern about health risks for children, adolescents, and adults. Currently, over half of US adults are overweight and upward trends in prevalence show no sign of slowing. A continuation of current trends seems quite likely to lead to substantial increases in the number of people affected by obesity-related health conditions and in premature mortality. The primary treatment for obesity continues to be behavioral weight loss therapy, an approach that uses behavioral strategies (e.g., self-monitoring, stimulus control, problem-solving) to help participants adhere to dietary and physical activity recommendations. Significant progress has been made with respect to short term weight loss research over the past twenty years, with short term weight losses approximately doubling during this time period. Unfortunately, long term weight losses remain disappointing. The typical pattern is for maximum weight loss to occur at 6 months, with weight regain following. During the year following treatment, participants typically regain 30% to 50% of their initial weight loss. Follow-up beyond 1 year indicates a pattern of continued weight gain.
Though long term weight loss maintenance remains a critical challenge for obesity treatment, important information regarding successful weight loss maintenance (e.g., high levels of physical activity, self-weighing, maintenance of a low-fat, low-calorie diet) has been derived from the National Weight Control Registry led by Drs Wing and Hill. Treatment studies have incorporated such strategies to enhance maintenance; however, the most intensive treatment phase typically occurs during weight loss initiation with the maintenance phase occurring after treatment novelty has faded. Although increasing treatment duration improves weight loss, there is a point of diminishing returns as people eventually stop attending intervention sessions. An alternative strategy to provide the critical support necessary for weight loss maintenance may be to recruit people who have recently lost weight to a maintenance-focused intervention
We will recruit up to 400 adult men and women who have recently lost at least 10% of their body weight and randomize them to either a Self-Directed Intervention or a Guided Intervention . Self- Directed participants will receive a core set of print materials describing key behaviors and skills necessary for successful weight loss maintenance and will review these materials with an intervention coach during two phone sessions. Guided participants will take part in a set of ten core phone sessions addressing key factors relevant to weight maintenance (e.g., high levels of physical activity). After completing these sessions, Guided participants will receive 8 monthly check in calls and then bimonthly calls for the rest of the study. Guided participants are also asked to report their weight weekly, either via the Keep It Off website, email or voicemail. Those who experience weight gain will receive outreach calls to assist them in reversing their recent weight gain. They will also receive bi-monthly tailored feedback reports based on whether they are maintaining, losing or gaining weight. We hypothesize that those in the Guided arm of the study will regain less weight than those in the self-directed arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Directed | Active comparator | Behavioral: Self-Directed (weight loss maintenance) |
| Guided | Active comparator | Behavioral: Guided (weight loss maintenance) |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 19 and 70
- HealthPartners members for 11 out of the past 12 months
- Have lost at least 10% of body weight in the last 12 months
Key exclusion criteria (10 listed)
- Lost weight via gastric by-pass surgery
- Modified Charlson scores >=3
- Nonskin cancer
- Congestive heart failure
- Coronary heart disease
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 |
|---|---|---|
| Self-Directed (weight loss maintenance)Self- Directed participants will receive a core set of print materials describing key behaviors and skills necessary for successful weight loss maintenance and will review these materials with an intervention coach in two sessions. | Behavioural | Self-Directed |
| Guided (weight loss maintenance)Guided participants will receive 8 monthly check in calls and then bimonthly calls for the rest of the study. Guided participants are also asked to report their weight weekly, either via the Keep It Off website, email or voicemail. Those who experience weight gain will receive outreach calls to assist them in reversing their weight gain. | Behavioural | Guided |
Primary outcome
Weight: Weight change in kilograms at 24 month follow-up. We hypothesize that Guided participants will regain less weight than the Self-Directed participants.
Time frame: 24 months
1 secondary outcome
assessments of subgroup analysis of intervention effectiveness (e.g., BMI status, weight loss method, gender.
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2012.
- Derived from this study: PubMed 28508330Crain AL, Sherwood NE, Martinson BC, Jeffery RW. Mediators of Weight Loss Maintenance in the Keep It Off Trial. Ann Behav Med. 2018 Jan 5;52(1):9-18. doi: 10.1007/s12160-017-9917-x.
- Derived from this study: PubMed 27923968Crane MM, Jeffery RW, Sherwood NE. Exploring Gender Differences in a Randomized Trial of Weight Loss Maintenance. Am J Mens Health. 2017 Mar;11(2):369-375. doi: 10.1177/1557988316681221. Epub 2016 Dec 5.
- Derived from this study: PubMed 24629554Senso MM, Anderson CP, Crain AL, Sherwood NE, Martinson BC. Self-reported activity and accelerometry in 2 behavior-maintenance trials. Am J Health Behav. 2014 Mar;38(2):254-64. doi: 10.5993/AJHB.38.2.11.
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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.
Nancy E. Sherwood, PhD principal investigator
HealthPartners Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Directed (weight loss maintenance) and Guided (weight loss maintenance) in people with Weight Loss Maintenance, run by HealthPartners Institute at 1 site 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 3 inclusion and 10 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 21 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Weight: Weight change in kilograms at 24 month follow-up. We hypothesize that Guided participants will regain less weight than the Self-Directed participants. (time frame: 24 months). 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 NCT00702455, which also lists 3 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 21 Nov 2012.