Trial Outcomes & Findings for Phone Coaching for Weight Loss Maintenance (NCT NCT04293055)

NCT ID: NCT04293055

Last Updated: 2024-12-31

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 77 participants
• Primary outcome timeframe: Baseline and Month 12
• Results posted on: 2024-12-31

Participant Flow

Participant milestones

Measure	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.	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
Overall Study STARTED	41	36
Overall Study Triggered Randomization	35	31
Overall Study Received Randomization Condition	33	31
Overall Study COMPLETED	34	30
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Measure	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.	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
Overall Study Lost to Follow-up	1	1
Overall Study Did not trigger randomization	6	5

Baseline Characteristics

Phone Coaching for Weight Loss Maintenance

Baseline characteristics by cohort

Measure	Maintenance Program+Possibility of Phone Coaching n=41 Participants 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.	Maintenance Program Only n=36 Participants 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	Total n=77 Participants Total of all reporting groups
Age, Continuous	52.2 years STANDARD_DEVIATION 10.5 • n=5 Participants	56.4 years STANDARD_DEVIATION 8.7 • n=7 Participants	54.1 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	25 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	33 Participants n=7 Participants	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized White	34 Participants n=5 Participants	30 Participants n=7 Participants	64 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized More than One Race	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants	36 participants n=7 Participants	77 participants n=5 Participants
BMI	29.4 kg/m^2 STANDARD_DEVIATION 4.4 • n=5 Participants	29.1 kg/m^2 STANDARD_DEVIATION 3.9 • n=7 Participants	29.2 kg/m^2 STANDARD_DEVIATION 4.2 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Maintenance Program+Possibility of Phone Coaching n=35 Participants 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.	Maintenance Program Only n=31 Participants 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
Percent Change in Body Weight From Baseline to Month 12	5.18 percent change Standard Error 0.72	5.71 percent change Standard Error 0.76

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Maintenance Program+Possibility of Phone Coaching n=35 Participants 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.	Maintenance Program Only n=31 Participants 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
Percent Weight Change Over the Coaching Period	-1.05 percent change Standard Error 0.3	0.37 percent change Standard Error 0.31

Adverse Events

Maintenance Program+Possibility of Phone Coaching

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Maintenance Program Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jacqueline Hayes

The Miriam Hospital

Phone: 401-793-8917

Email: jhayes3@lifespan.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place