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The purpose of this study was to examine whether 4 consecutive weeks of phone coaching aids in recovery from weight regain during weight loss maintenance. Individuals who previously achieved and maintained a >=5% weight loss in a 1-year behavioral weight loss program were provided with a low-intensity maintenance intervention (monthly newsletters and smart scale). At baseline, participants were randomized to the coaching group or the control group (no coaching). If participants regained >1.5% of their weight, randomization was "triggered." At this point, participants randomized to the coaching condition received 4 brief weekly coaching calls; participants randomized to the control condition received no additional intervention contact. Short-term and long-term weight change was assessed and compared between treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maintenance program+possibility of phone coaching | Experimental | All participants are provided with a monthly newsletter which contains useful strategies for maintaining weight loss long-term. Participants are also encouraged to weigh themselves daily using a smart scale, which electronically transmits weight data to the research staff. Some participants randomized to this condition will also receive 4 consecutive weeks of phone coaching at some point over the 1-year intervention period (this is determined by a weight-based algorithm). |
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| Maintenance program only | Active Comparator | All participants are provided with a monthly newsletter which contains useful strategies for maintaining weight loss long-term. Participants are also encouraged to weigh themselves daily using a smart scale, which electronically transmits weight data to the research staff. No participants in this condition will receive phone coaching. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maintenance program | Behavioral | 1-year weight loss maintenance program, consisting of monthly newsletters |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Body Weight From Baseline to Month 12 | Baseline and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Weight Change Over the Coaching Period | The 'coaching period' weight change was calculated by subtracting the 'trigger date' weight (i.e., the weight measurement from the smart scale on the day the participant achieved the trigger threshold, which was defined as the final day in a series of 4 days >1.5% or the final day in which the previous 7 days averaged >1.5%) from the smart scale weight 40 days following the 'trigger date'. Percent weight change was then calculated by taking the 'coaching period weight change' and dividing it by the 'trigger date weight' and multiplying by 100. Therefore, a negative number indicates weight loss and a positive number indicates weight gain over the 40-day coaching period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica L Unick, PhD | The Miriam Hospital's Weight Control and Diabetes Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Miriam Hospital's Weight Control and Diabetes Research Center | Providence | Rhode Island | 02903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40569564 | Derived | Hayes JF, Ross KM, Pellegrini C, Wing RR, Webster J, Derrick A, Tobin SY, Unick JL. Brief coaching intervention to reverse weight regain during weight loss maintenance: a preliminary randomized controlled trial. J Behav Med. 2025 Aug;48(4):706-714. doi: 10.1007/s10865-025-00582-x. Epub 2025 Jun 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Maintenance Program+Possibility of Phone Coaching | All participants are provided with a monthly newsletter which contains useful strategies for maintaining weight loss long-term. Participants are also encouraged to weigh themselves daily using a smart scale, which electronically transmits weight data to the research staff. Some participants randomized to this condition will also receive 4 consecutive weeks of phone coaching at some point over the 1-year intervention period (this is determined by a weight-based algorithm). Maintenance program: 1-year weight loss maintenance program, consisting of monthly newsletters Phone coaching: Some individuals will receive 4 consecutive weeks of phone coaching. The first coaching call will be approximately 30 minutes in duration and follow-up calls will be 10-15 minutes in duration. Coaches will help support participants in their weight loss maintenance efforts. Once coaching calls are completed, the participant will not have any other contact with their coach. |
| FG001 | Maintenance Program Only | All participants are provided with a monthly newsletter which contains useful strategies for maintaining weight loss long-term. Participants are also encouraged to weigh themselves daily using a smart scale, which electronically transmits weight data to the research staff. No participants in this condition will receive phone coaching. Maintenance program: 1-year weight loss maintenance program, consisting of monthly newsletters |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Maintenance Program+Possibility of Phone Coaching | All participants are provided with a monthly newsletter which contains useful strategies for maintaining weight loss long-term. Participants are also encouraged to weigh themselves daily using a smart scale, which electronically transmits weight data to the research staff. Some participants randomized to this condition will also receive 4 consecutive weeks of phone coaching at some point over the 1-year intervention period (this is determined by a weight-based algorithm). Maintenance program: 1-year weight loss maintenance program, consisting of monthly newsletters Phone coaching: Some individuals will receive 4 consecutive weeks of phone coaching. The first coaching call will be approximately 30 minutes in duration and follow-up calls will be 10-15 minutes in duration. Coaches will help support participants in their weight loss maintenance efforts. Once coaching calls are completed, the participant will not have any other contact with their coach. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Body Weight From Baseline to Month 12 | Only individuals who regained 1.5% weight and triggered randomization condition were included in the analysis. Multiple imputation used to correct for missing data. | Posted | Mean | Standard Error | percent change | Baseline and Month 12 |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Maintenance Program+Possibility of Phone Coaching | All participants are provided with a monthly newsletter which contains useful strategies for maintaining weight loss long-term. Participants are also encouraged to weigh themselves daily using a smart scale, which electronically transmits weight data to the research staff. Some participants randomized to this condition will also receive 4 consecutive weeks of phone coaching at some point over the 1-year intervention period (this is determined by a weight-based algorithm). Maintenance program: 1-year weight loss maintenance program, consisting of monthly newsletters Phone coaching: Some individuals will receive 4 consecutive weeks of phone coaching. The first coaching call will be approximately 30 minutes in duration and follow-up calls will be 10-15 minutes in duration. Coaches will help support participants in their weight loss maintenance efforts. Once coaching calls are completed, the participant will not have any other contact with their coach. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jacqueline Hayes | The Miriam Hospital | 401-793-8917 | jhayes3@lifespan.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 28, 2020 | Aug 9, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 6, 2024 | Aug 9, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Phone coaching | Behavioral | Some individuals will receive 4 consecutive weeks of phone coaching. The first coaching call will be approximately 30 minutes in duration and follow-up calls will be 10-15 minutes in duration. Coaches will help support participants in their weight loss maintenance efforts. Once coaching calls are completed, the participant will not have any other contact with their coach. |
|
| Trigger date and 40 days post-trigger date |
| BG001 | Maintenance Program Only | All participants are provided with a monthly newsletter which contains useful strategies for maintaining weight loss long-term. Participants are also encouraged to weigh themselves daily using a smart scale, which electronically transmits weight data to the research staff. No participants in this condition will receive phone coaching. Maintenance program: 1-year weight loss maintenance program, consisting of monthly newsletters |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Maintenance Program Only | All participants are provided with a monthly newsletter which contains useful strategies for maintaining weight loss long-term. Participants are also encouraged to weigh themselves daily using a smart scale, which electronically transmits weight data to the research staff. No participants in this condition will receive phone coaching. Maintenance program: 1-year weight loss maintenance program, consisting of monthly newsletters |
|
|
| Secondary | Percent Weight Change Over the Coaching Period | The 'coaching period' weight change was calculated by subtracting the 'trigger date' weight (i.e., the weight measurement from the smart scale on the day the participant achieved the trigger threshold, which was defined as the final day in a series of 4 days >1.5% or the final day in which the previous 7 days averaged >1.5%) from the smart scale weight 40 days following the 'trigger date'. Percent weight change was then calculated by taking the 'coaching period weight change' and dividing it by the 'trigger date weight' and multiplying by 100. Therefore, a negative number indicates weight loss and a positive number indicates weight gain over the 40-day coaching period. | Posted | Mean | Standard Error | percent change | Trigger date and 40 days post-trigger date |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Maintenance Program Only | All participants are provided with a monthly newsletter which contains useful strategies for maintaining weight loss long-term. Participants are also encouraged to weigh themselves daily using a smart scale, which electronically transmits weight data to the research staff. No participants in this condition will receive phone coaching. Maintenance program: 1-year weight loss maintenance program, consisting of monthly newsletters | 0 | 36 | 0 | 36 | 0 | 36 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |