Obesity, Weight Loss
Conditions
Keywords
Phone coaching, Diet, Exercise
Brief summary
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.
Interventions
BEHAVIORALMaintenance program
1-year weight loss maintenance program, consisting of monthly newsletters
BEHAVIORALPhone 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.
Sponsors
The Miriam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 72 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-72 years of age * Recent completion of a 1-year behavioral weight loss program * Achievement of \>=5% weight loss at the end of the 1-year weight loss program
Exclusion criteria
* Not currently enrolled in another weight management program
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change in Body Weight From Baseline to Month 12 | Baseline and Month 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Weight Change Over the Coaching Period | Trigger date and 40 days post-trigger date | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 41 |
| 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 | 36 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not trigger randomization | 6 | 5 |
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Maintenance Program Only | Total | Maintenance Program+Possibility of Phone Coaching |
|---|---|---|---|
| Age, Continuous | 56.4 years STANDARD_DEVIATION 8.7 | 54.1 years STANDARD_DEVIATION 9.9 | 52.2 years STANDARD_DEVIATION 10.5 |
| BMI | 29.1 kg/m^2 STANDARD_DEVIATION 3.9 | 29.2 kg/m^2 STANDARD_DEVIATION 4.2 | 29.4 kg/m^2 STANDARD_DEVIATION 4.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 6 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 71 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 3 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized More than One Race | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 30 Participants | 64 Participants | 34 Participants |
| Region of Enrollment United States | 36 participants | 77 participants | 41 participants |
| Sex: Female, Male Female | 25 Participants | 54 Participants | 29 Participants |
| Sex: Female, Male Male | 11 Participants | 23 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 36 |
| other Total, other adverse events | 0 / 41 | 0 / 36 |
| serious Total, serious adverse events | 0 / 41 | 0 / 36 |
Outcome results
Primary
Percent Change in Body Weight From Baseline to Month 12
Time frame: Baseline and Month 12
Population: Only individuals who regained 1.5% weight and triggered randomization condition were included in the analysis. Multiple imputation used to correct for missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Program+Possibility of Phone Coaching | Percent Change in Body Weight From Baseline to Month 12 | 5.18 percent change | Standard Error 0.72 |
| Maintenance Program Only | Percent Change in Body Weight From Baseline to Month 12 | 5.71 percent change | Standard Error 0.76 |
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.
Time frame: Trigger date and 40 days post-trigger date
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Program+Possibility of Phone Coaching | Percent Weight Change Over the Coaching Period | -1.05 percent change | Standard Error 0.3 |
| Maintenance Program Only | Percent Weight Change Over the Coaching Period | 0.37 percent change | Standard Error 0.31 |